NEOWIRE PTA/PTCA GUIDEWIRE

• K Number: K101729
• Device Name: NEOWIRE PTA/PTCA GUIDEWIRE
• Manufacturer: NEO METRICS, INC.
• Date Cleared: 2010-09-23 ( 94 days)
• Product Code: DQX
• Regulation Number: 870.1330

Intended Use

The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.

Device Description

NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.

Predicate Devices

K070150, K983927, K013024, K082304, K081337

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical guidewire and does not mention any AI or ML components or functionalities.

Therapeutic

No.
The NeoWire Guidewire is an accessory device (guidewire) used to facilitate the introduction and placement of other catheters and interventional devices, rather than directly treating a disease or condition itself.

Diagnostic

No

The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices, which is an interventional or therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical guidewire constructed of nitinol alloy, not a software application.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
• NeoWire Guidewire Function: The description clearly states the NeoWire Guidewire is intended to "facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature." This is a device used within the body (in vivo) to guide other medical instruments.
• Lack of Diagnostic Testing: There is no mention of this device being used to perform any kind of test on a biological sample or to provide diagnostic information based on such testing.

The NeoWire Guidewire is an interventional medical device used for procedural guidance, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.

Product codes

DQX

Device Description

NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and/or peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing of the NeoWire Guidewire includes bench testing, biocompatibility testing, shelflife and packaging testing and sterilization evaluation. Bench testing, shelf-life testing, and sterilization testing were conducted on NeoWire. Biocompatibility testing was conducted on NeoWire and leveraged from other previously cleared NeoMetrics products.

To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices:

• Guidewire Dimensions (overall length, radiopaque tip length, and diameter) per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
• Torqueability and Torque Strength per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
• Coating Adherence per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
• Tip Flexibility per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
• Sterile Package Integrity per ASTM F 1929-98
• Sterile Package Integrity per ASTM F 88-09
• Reverse Bend (Fatigue Failure) per ISO 11070
• Tensile testing per ISO 11070
• Fracture Resistance per ISO 11070
• Corrosion Resistance per ISO 11070
• Tip Load per NeoMetrics' test method TM-3010
• Rail Support per NeoMetrics' test method TM-3002

Results of this testing demonstrate that the guidewire design meets the product specifications and intended uses.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K070150, K983927, K013024, K082304, K081337

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

KCO1729

Section 5.0: 510(k) Summary

SEP 2 3 2010

5.1 Administrative Information

Name:	NeoMetrics, Inc.
Address:	2605 Fernbrook Lane North, Suite
Plymouth, MN 55447
Contact Person:	Gene Champeau
Title:	President
Phone:	(763)-559-4440
Fax:	[phone]
FDA Registration Number:	2135342
Date:	April 2, 2010

5.2 Device Information

Name of Device:	NeoWire PTA/PTCA Guidewire
Common Name:	Guides, Guidewires, or spring Guidewires
Classification Name:	Catheter Guide Wire (870.1330)
Product Code:	DQX

5.3 Predicate Device Information

The following commercially available guidewires are predicate devices for NeoWire.

510(k) Number	Trade or Model Name	Manufacturer
K070150	VascuPuncture PICC Guidewire	NeoMetrics, Inc.
K983927	Zinger Guidewire	Medtronic
K013024	Selectiva	NeoMetrics, Inc.
K082304	Roll-X	St. Jude Medical
K081337	Approach CTO	Cook

5.4 Device Description

NeoWire is a steerable guidewire constructed of a nitinol alloy core with a coiled segment on the distal end. The core wire is either PTFE coated or uncoated and the wire may also contain silicone or hydrophilic lubricious coatings. This distal end of the wire can be shapeable and is radiopaque.

5.5 Intended Use

The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (≤ 9g) are intended for peripheral or coronary use. The guidewire is not intended for use in the cerebral vasculature.

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5.6 Technological Characteristics

A comparison of the characteristics of the proposed device to the predicate devices show the proposed device to have the following same or similar technological characteristics to the devices which have received 510(k) clearance:

• . Same intended use;
• . Same operating principle;
• . Same shelf life and sterilization process;
• Similarities in Design, Material Types, and Technology include: .
  • Nominal diameters: 0.014" and 0.018" o
  • Similar Lengths: 80, 180 190, and 300cm o
  • Nitinol alloy core wires o
  • Distal radiopaque coils o
  • 0 Flexible, shapeable distal tip segments
  • o Joined by a combination of adhesive and welds
  • o Lubricious coatings

To ascertain similarity, the following performance testing was conducted on both the proposed device and the predicate devices:

• . Guidewire Dimensions (overall length, radiopaque tip length, and diameter) per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
• . Torqueability and Torque Strength per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995
• . Coating Adherence per FDA Coronary and Cerebrovascular Guidewire Guidance January 1 ਰੇਰੇਟ
• Tip Flexibility per FDA Coronary and Cerebrovascular Guidewire Guidance January 1995 .
• . Sterile Package Integrity per ASTM F 1929-98
• Sterile Package Integrity per ASTM F 88-09 .
• Reverse Bend (Fatigue Failure) per ISO 11070 .
• Tensile testing per ISO 11070
• . Fracture Resistance per ISO 11070
• Corrosion Resistance per ISO 11070 .
• . Tip Load per NeoMetrics' test method TM-3010
• . Rail Support per NeoMetrics' test method TM-3002

Due to the destructive nature of the tests and the availability of predicate devices not all testing was conducted on each predicate device, however competitive devices were tested along with the proposed device in each test.

5.7 Summary of Non-Clinical Testing

Non-clinical testing of the NeoWire Guidewire includes bench testing, biocompatibility testing, shelflife and packaging testing and sterilization evaluation. Bench testing, shelf-life testing, and sterilization testing were conducted on NeoWire. Biocompatibility testing was conducted on NeoWire and leveraged from other previously cleared NeoMetrics products. A summary table of the test data source is shown:

2

	Tested and Leveraged Biocomaptibility Data
Test Guidance
Document	ISO 10993-4	ISO 10993-4
(ASTM
Guideline
F-756-00)	ISO 10993-5	ISO 10993-11	ISO-10993-10	ISO 10993-10
Material	Partial
Thromboplastin
Time (PTT)	ASTM
Hemolysis Assay
Direct Contact
Method	MEM Elution
Assay with L-
929 Mouse
Fibroblast Cells
(Cytotoxicity)	Acute Systemic
Injection Test	Intracutaneous
Reactivity Test	Guinea Pig
Maximization
Sensitization
Test	Complement
Activation	In Vivo
Thrombosis
(Thrombo-
genicity)
Core Wire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire
Hydrophilic
Coating	Leveraged	Leveraged	Leveraged	Leveraged	Leveraged	Leveraged	Tested on
NeoWire	Tested on
NeoWire
Silicone
Coating	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Leveraged	Leveraged
Proximal Coll
(dual coll
designs)	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Leveraged	Leveraged
Radiopaque
Distal Coll
(Option 1)	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire
Radiopaque
Distal Coll
(Option 2)	Leveraged
Tested on
NeoWire	Leveraged
Tested on
NeoWire	Leveraged
Tested on
NeoWire	Leveraged
Tested on
NeoWire	Leveraged
Tested on
NeoWire	Leveraged
Tested on
NeoWire	Leveraged	Leveraged
Adhesive	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Leveraged	Leveraged
PTFE Coating	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire	Tested on
NeoWire

Results of this testing demonstrate that the guidewire design meets the product specifications and intended uses.

5.8 Substantial Equivalence Conclusion

The NeoWire Guidewire described in this 510(k) is substantially equivalent to the devices listed in section 5.3. The intended use, design, material types, technology, and performance of the NeoWire Guidewire are equivalent to the predicate devices. There are no differences between devices which would raise issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

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

NeoMetrics, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW Buffalo, MN 55313

SEP 2 3 2010

Re: K101729

Trade/Device Name: NeoWire PTA/PTCA Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: September 7, 2010 Received: September 8, 2010

Dear Mr. Job:

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.

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.

4

Page 2 - Mr. Mark Job

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

.z

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

Enclosure

5

K101729

Section 4: Indications for Use Statement

SEP 2 3 2010

Indications for Use

510(k) Number (if known): unavailable

Device Name: NeoWire PTA/PTCA Guidewire

Indications for Use:

The NeoWire Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices within the coronary and/or peripheral vasculature. Models with Stiff tips (> 9g) are intended for peripheral use only. Models with Floppy, Soft, and Medium tips (S 9g) are intended for peripheral or coronary use. The guldewire is not intended for use in the cerebral vasculature.

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

Over-The-Counter Use: (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

$\mu PDZ

ivision Sign-Off) Division of Cardiovascular Devices

510(k) Number: K101729