To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

Device Description

The HI-TORQUE BALANCE Guide Wires are available in a 0.014" outer diameter, in 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE TREK Guide Wires are available in a 0.014" outer diameter, and in an 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE HEAVYWEIGHT Guide Wires are available in a 0.014" outer diameter, in 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of the adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires are available in a 0.014" outer diameter, 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of the adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire is a steerable guide wire available in a maximum outer diameter of 0.0137" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The BMW Universal Guide Wire is DOC® extendable in the 190 cm lengths. The change being made is to the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TOROUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology. The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wire is a steerable guide wire available in a maximum outer diameter of 0.014" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0145". The proximal end of the guide wire is coated with hydrophobic coating, which reduces friction of the wire within a catheter. The ELITE Guide Wire is DOC® extendable in the 190 cm lengths. The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

AI/ML Overview

The provided text describes the 510(k) summary for various HI-TORQUE BALANCE Guide Wires by Abbott Vascular. The device is a guide wire used in percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The specific subject of this 510(k) is a change in the formulation of an adhesive used to adhere two core subassemblies within the guide wires.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for the Modified Adhesive Formulation:

Performance Metric	Acceptance Criteria	Reported Device Performance
Mechanical Integrity	Tensile strength of distal to proximal core joint must be sufficient to withstand normal tensile loading during clinical use.	The tensile strength to join the distal core with the proximal core of the guidewire was conducted. The hypotube pull test verified that the hypotube joint is sufficiently strong to withstand normal tensile loading during the use of the Guide Wire in a clinical procedure.
Adhesive Functionality	Functionality of the modified adhesive formulation must maintain appropriate performance for intended use.	Bench testing and biocompatibility testing confirmed that the device with the modified adhesive formulation remains appropriate for its intended use.
Biocompatibility (General Safety)	The modified adhesive formulation must pass a battery of specified biocompatibility tests.	The modified adhesive formulation was tested and results are reported to confirm biocompatibility.
Overall Safety & Effectiveness	No new safety or effectiveness issues should be raised compared to predicate devices.	No new safety or effectiveness issues were raised during the testing, and the devices are considered substantially equivalent to predicate devices.

Biocompatibility Specific Tests:

Biocompatibility Test	Acceptance Criteria	Reported Device Performance
a. Cytotoxicity	Must be non-toxic	Tested, results confirm appropriate for use
b. Hemolysis, direct	Must not cause direct hemolysis	Tested, results confirm appropriate for use
c. Hemolysis, indirect	Must not cause indirect hemolysis	Tested, results confirm appropriate for use
d. Complement Activation	Must not activate complement	Tested, results confirm appropriate for use
e. Coagulation (PT and PTT)	Must not interfere with coagulation	Tested, results confirm appropriate for use
f. Sensitization	Must not cause sensitization	Tested, results confirm appropriate for use
g. Intracutaneous Toxicity (Irritation)	Must not cause irritation	Tested, results confirm appropriate for use
h. Acute Systemic Toxicity	Must not cause acute systemic toxicity	Tested, results confirm appropriate for use
i. Pyrogenicity Material Mediated (Rabbit)	Must not be pyrogenic	Tested, results confirm appropriate for use

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the numerical sample size for the mechanical performance tests or the biocompatibility tests. It only mentions that "In vitro bench testing performance evaluations demonstrated..." and "Bench testing and Biocompatibility testing was conducted...".
Data Provenance: The studies were retrospective in the sense that they were conducted for the purpose of demonstrating substantial equivalence for a specific change (adhesive formulation) to existing, legally marketed devices. The origin of the data is Abbott Vascular's internal testing facilities, as implied by the submission on behalf of Abbott Vascular. No country of origin for the data (beyond the applicant's location, USA/Germany for contact) is specified, but it's standard industry practice for such testing to be conducted in-house or by accredited labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts and Qualifications: This information is not provided in the document. For bench and biocompatibility testing, ground truth is typically established by adhering to recognized international standards (e.g., ISO for biocompatibility) and internal company specifications, rather than expert consensus on individual test outcomes. The "experts" would be the engineers, scientists, and toxicologists conducting and interpreting these tests, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not discussed. Since the studies described are bench tests and biocompatibility assessments, not clinical studies or image interpretations, there is no mention of an adjudication method like 2+1 or 3+1. Performance is assessed against pre-defined engineering specifications and standardized biological response criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (guide wire), specifically addressing a material change (adhesive formulation). It does not involve AI or human readers, so an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Study: No, a standalone algorithm-only study was not done. This submission is for a physical medical device, not an algorithm or AI product.

7. The Type of Ground Truth Used

Type of Ground Truth:
- For mechanical integrity (tensile strength, hypotube pull test): The ground truth is defined by engineering specifications and performance criteria designed to ensure the device can withstand normal tensile loading during clinical procedures. This is typically established through risk analysis and functional requirements.
- For biocompatibility: The ground truth is established by international standards and regulatory guidelines (e.g., ISO 10993 series) for evaluating the biological effects of medical devices. Passing these standardized tests establishes the material's safety for biological contact.

8. The Sample Size for the Training Set

Sample Size for Training Set: This is not applicable as there is no mention of a training set. This submission is for a physical medical device and its material change, not an AI/machine learning model that requires training data.

9. How the Ground Truth for the Training Set was Established

Ground Truth Establishment for Training Set: This is not applicable as there is no training set involved.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2015

Abbott Vascular Jochen Reich Senior Regulatory Affairs Specialist 26531 Ynez Road Temecula, California 92591

Re: K152709

Trade/Device Name: Hi-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek, Balance Middleweight Universal, Balance Middleweight Universal II, Balance Middleweight Elite Guide wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: September 18, 2015 Received: September 21, 2015

Dear Jochen Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrand

for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K152709

Device Name: HI-TORQUE BALANCE Guide Wires and HI-TORQUE BALANCE Guide Wires with Hydrocoat Hydrophilic Coating

Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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510(k) Number (if known): _K152709

Device Name: HI-TORQUE BALANCE TREK Guide Wires with Hydrocoat Hydrophilic Coating

Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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510(k) Number (if known): _K152709

Device Name: HI-TORQUE BALANCE HEAVYWEIGHT Guide Wires with Hydrocoat Hydrophilic Coating

Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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510(k) Number (if known): _K152709

Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires and HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires with Hydrocoat Hydrophilic Coating

Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number (if known): _K152709

Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wires with Hydrophilic Coating

Indications for Use:

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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510(k) Number (if known): _K152709

Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wires

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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510(k) Number (if known): K152709

Device Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wires

Indications for Use:

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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510(k) Summary

A) HI-TORQUE BALANCE Guide Wires

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. Submitter's Name	Abbott Vascular
2. Submitter's Address	26531 Ynez Road, Temecula, CA 92591
3. Telephone	0049-15165621396
4. Fax	(951) 914-0339
5. Contact Person	Jochen Reich
6. Date Prepared	September 28, 2015
7. Device Trade Name	HI-TORQUE BALANCE
8. Device Common Name	Coronary Guide Wire
9. Device Classification Name	Catheter Guide Wire (DQX)
10. Predicate Device Name	HI-TORQUE BALANCE Guide Wire (K925381.
	cleared February 12, 1993), HI-TORQUE
	BALANCE Guide Wire with Hydrocoat
	Hydrophilic Coating, (K973494, cleared December
	12, 1997) and HI-TORQUE BALANCE Guide
	Wire. (K021228, cleared May 15, 2002)

11. Device and Change Description

12. Indication for Use

The HI-TORQUE BALANCE Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

13. Technological Characteristics

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In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE Guide Wires met the acceptance criteria and performed comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing and therefore, the HI-TORQUE BALANCE Guide Wire Family may be considered substantially equivalent to the predicate devices.

Bench testing and Biocompatibility testing was conducted and the results confirm that the device with the modified adhesive formulation remains appropriate for its intended use.

As for bench testing the tensile strength to join the distal core of the guidewire (where the tip coil is located) with the proximal core of the guidewire was conducted. The hypotube pull test verified that the hypotube joint is sufficiently strong to withstand normal tensile loading during the use of the Guide Wire in a clinical procedure.

The modified adhesive formulation was tested for biocompatibility as per the below listed biocompatibility tests:

a. Cytotoxicity
b. Hemolysis, direct
c. Hemolysis, indirect
d. Complement Activation
e. Coagulation (PT and PTT)
f. Sensitization
g. Intracutaneous Toxicity (Irritation)
h. Acute Systemic Toxicity
Pyrogenicity Material Mediated (Rabbit) i.

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B) HI-TORQUE BALANCE TREK Guide Wires

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. Submitter's Name	Abbott Vascular
2. Submitter's Address	26531 Ynez Road, Temecula, CA 92591
3. Telephone	0049-15165621396
4. Fax	(951) 914-0339
5. Contact Person	Jochen Reich
6. Date Prepared	September 28, 2015
7. Device Trade Name	HI-TORQUE BALANCE TREK
8. Device Common Name	Coronary Guide Wire
9. Device Classification Name	Catheter Guide Wire (DQX)
10. Predicate Device Name	HI-TORQUE BALANCE TREK Guide Wire(K991152, cleared April 29, 1999) and HI-TORQUE BALANCE TREK Guide Wire,(K021228, cleared May 15, 2002)

11. Device Description

Indication for Use

The HI-TORQUE BALANCE TREK Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

13. Technological Characteristics

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In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE TREK Guide Wires met the acceptance criteria and performed comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing and therefore, the HI-TORQUE BALANCE TREK Guide Wire Family may be considered substantially equivalent to the predicate devices.

Bench testing and Biocompatibility testing was conducted and the results confirm that the device with the modified adhesive formulation remains appropriate for its intended use.

The modified adhesive formulation was tested for biocompatibility as per the below listed biocompatibility tests:

a. Cytotoxicity
b. Hemolysis, direct
c. Hemolysis, indirect
d. Complement Activation
e. Coagulation (PT and PTT)
f. Sensitization
g. Intracutaneous Toxicity (Irritation)
h. Acute Systemic Toxicity
Pyrogenicity Material Mediated (Rabbit) i.

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C) HI-TORQUE BALANCE HEAVYWEIGHT Guide Wires

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. Submitter's Name	Abbott Vascular
2. Submitter's Address	26531 Ynez Road, Temecula, CA 92591
3. Telephone	0049-15165621396
4. Fax	(951) 914-0339
5. Contact Person	Jochen Reich
6. Date Prepared	September 28, 2015
7. Device Trade Name	HI-TORQUE BALANCE HEAVYWEIGHT
8. Device Common Name	Coronary Guide Wire
9. Device Classification Name	Catheter Guide Wire (DQX)
10. Predicate Device Name	HI-TORQUE BALANCE HEAVYWEIGHTGuide Wire with Hydrocoat Hydrophilic Coating(K982083, cleared September 11, 1998) and HI-TORQUE BALANCE HEAVYWEIGHT GuideWire, (K021228, cleared May 15, 2002)

11. Device Description

12. Indication for Use

The HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

13. Technological Characteristics

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In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE HEAVYWEIGHT Guide Wires met the acceptance criteria and performed comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing and therefore, the HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire Family may be considered substantially equivalent to the predicate devices.

Bench testing and Biocompatibility testing was conducted and the results confirm that the device with the modified adhesive formulation remains appropriate for its intended use.

The modified adhesive formulation was tested for biocompatibility as per the below listed biocompatibility tests:

a. Cytotoxicity
b. Hemolysis, direct
c. Hemolysis, indirect
d. Complement Activation
e. Coagulation (PT and PTT)
Sensitization f.
g. Intracutaneous Toxicity (Irritation)
h. Acute Systemic Toxicity
Pyrogenicity Material Mediated (Rabbit) i.

{15}------------------------------------------------

D) HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. Submitter's Name	Abbott Vascular
2. Submitter's Address	26531 Ynez Road, Temecula, CA 92591
3. Telephone	0049-15165621396
4. Fax	(951) 914-0339
5. Contact Person	Jochen Reich
6. Date Prepared	September 28, 2015
7. Device Trade Name	HI-TORQUE BALANCE MIDDLEWEIGHT
8. Device Common Name	Coronary Guide Wire
9. Device Classification Name	Catheter Guide Wire (DQX)
10. Predicate Device Name	HI-TORQUE BALANCE MIDDLEWEIGHTGuide Wire (K971815, cleared July 9, 1997), HI-TORQUE BALANCE MIDDLEWEIGHT GuideWire with Hydrocoat Hydrophilic Coating(K973494, cleared December 12, 1997) and HI-TORQUE BALANCE MIDDLEWEIGHT GuideWire, (K021228, cleared May 15, 2002)

11. Device Description

12. Indication for Use

The HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

13. Technological Characteristics

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In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires met the acceptance criteria and performed comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing and therefore. the HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire Family may be considered substantially equivalent to the predicate devices.

Bench testing and Biocompatibility testing was conducted and the results confirm that the device with the modified adhesive formulation remains appropriate for its intended use.

The modified adhesive formulation was tested for biocompatibility as per the below listed biocompatibility tests:

a. Cytotoxicity
b. Hemolysis, direct
c. Hemolysis, indirect
d. Complement Activation
e. Coagulation (PT and PTT)
Sensitization f.
g. Intracutaneous Toxicity (Irritation)
h. Acute Systemic Toxicity
Pyrogenicity Material Mediated (Rabbit) i.

{17}------------------------------------------------

E) HI-TOROUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wires

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1.	Submitter's Name	Abbott Vascular
2.	Submitter's Address	26531 Ynez Road, Temecula, CA 92591
	3. Telephone	0049-15165621396
	4. Fax	(951) 914-0339
	5. Contact Person	Jochen Reich
	6. Date Prepared	September 28, 2015
	7. Device Trade Name	HI-TORQUE BALANCE MIDDLEWEIGHT
		UNIVERSAL
	8. Device Common Name	Coronary Guide Wire
	9. Device Classification Name	Catheter Guide Wire (DQX)
	10. Predicate Device Name	HI-TORQUE BALANCE MIDDLEWEIGHT
		UNIVERSAL Guide Wire with Hydrocoat
		Hydrophilic Coating (K013833, cleared January
		16, 2002), HI-TORQUE BALANCE
		MIDDLEWEIGHT UNIVERSAL Guide Wire
		with Hydrocoat Hydrophilic Coating (K031678
		cleared August 26, 2003) and HI-TORQUE
		BALANCE MIDDLEWEIGHT UNIVERSAL
		Guide Wire, (K101011, cleared May 24, 2010)

11. Device Description

12. Indication for Use

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

{18}------------------------------------------------

13. Technological Characteristics

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, materials, design, sterilization, packaging, and intended use are substantially equivalent to the current marketed predicate devices.

14. Performance Data

In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wires met the acceptance criteria and performed comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing and therefore, the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire Family may be considered substantially equivalent to the predicate devices.

Bench testing and Biocompatibility testing was conducted and the results confirm that the device with the modified adhesive formulation remains appropriate for its intended use.

The modified adhesive formulation was tested for biocompatibility as per the below listed biocompatibility tests:

a. Cytotoxicity
b. Hemolysis, direct
c. Hemolysis, indirect
d. Complement Activation
e. Coagulation (PT and PTT)
f. Sensitization
g. Intracutaneous Toxicity (Irritation)
h. Acute Systemic Toxicity
i. Pyrogenicity Material Mediated (Rabbit)

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E) HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wires

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. Submitter's Name	Abbott Vascular
2. Submitter's Address	26531 Ynez Road, Temecula, CA 92591
3. Telephone	0049-15165621396
4. Fax	(951) 914-0339
5. Contact Person	Jochen Reich
6. Date Prepared	September 28, 2015
7. Device Trade Name	HI-TORQUE BALANCE MIDDLEWEIGHTUNIVERSAL II
8. Device Common Name	Coronary Guide Wire
9. Device Classification Name	Catheter Guide Wire (DQX)
10. Predicate Device Name	HI-TORQUE BALANCE MIDDLEWEIGHTUNIVERSAL II Guide (K072460, cleared April 4,2008).

11. Device Description

Indication for Use

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

13. Technological Characteristics

{20}------------------------------------------------

In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wires met the acceptance criteria and performed comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing and therefore, the HI-TOROUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire Family may be considered substantially equivalent to the predicate devices.

Bench testing and Biocompatibility testing was conducted and the results confirm that the device with the modified adhesive formulation remains appropriate for its intended use.

The modified adhesive formulation was tested for biocompatibility as per the below listed biocompatibility tests:

a. Cytotoxicity
b. Hemolysis, direct
c. Hemolysis, indirect
d. Complement Activation
e. Coagulation (PT and PTT)
f. Sensitization
g. Intracutaneous Toxicity (Irritation)
h. Acute Systemic Toxicity
Pyrogenicity Material Mediated (Rabbit) i.

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F) HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wires

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

1. Submitter's Name	Abbott Vascular
2. Submitter's Address	26531 Ynez Road, Temecula, CA 92591
3. Telephone	0049-15165621396
4. Fax	(951) 914-0339
5. Contact Person	Jochen Reich
6. Date Prepared	September 28, 2015
7. Device Trade Name	HI-TORQUE BALANCE MIDDLEWEIGHTELITE
8. Device Common Name	Coronary Guide Wire
9. Device Classification Name	Catheter Guide Wire (DQX)
10. Predicate Device Name	HI-TORQUE BALANCE MIDDLEWEIGHTELITE Guide (K103101, cleared February 10, 2011).

11. Device Description

Indication for Use

The HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

13. Technological Characteristics

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In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wires met the acceptance criteria and performed comparable to the predicate devices. No new safety or effectiveness issues were raised during the testing and therefore, the HI-TOROUE BALANCE MIDDLEWEIGHT ELITE Guide Wire Family may be considered substantially equivalent to the predicate devices.

Bench testing and Biocompatibility testing was conducted and the results confirm that the device with the modified adhesive formulation remains appropriate for its intended use.

The modified adhesive formulation was tested for biocompatibility as per the below listed biocompatibility tests:

a. Cytotoxicity
b. Hemolysis, direct
c. Hemolysis, indirect
d. Complement Activation
e. Coagulation (PT and PTT)
f. Sensitization
g. Intracutaneous Toxicity (Irritation)
h. Acute Systemic Toxicity
Pyrogenicity Material Mediated (Rabbit) i.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.