To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter, and HemoSplit™ Long-Term Hemodialysis Catheter.

Device Description

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

AI/ML Overview

Here's an analysis of the provided text regarding the HemoSplit Repair Kit, focusing on the acceptance criteria and study information:

HemoSplit Repair Kit: Acceptance Criteria and Study Information

Note: The provided documentation (K030442) is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) or a more extensive clinical trial report would. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement, and advanced study methodologies like MRMC or standalone performance, is not present in this document. The "study" here is largely based on demonstrating equivalence rather than new performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are interpreted as the requirements for demonstrating substantial equivalence, and the "reported device performance" is framed in terms of meeting those equivalence criteria.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance (as per 510(k))
Same Indication Statement	No. The new device's indication statement changed to remove a generic trade name and add the HemoSplit™ catheter to the list of repairable catheters.
Differences Alter Intended Therapeutic Effect?	No. Stated as "No, the intended use is the same. There is only the addition of a catheter trade name to the list of repairable catheters."
Same Intended Use?	Yes. Stated as "Yes, the intended use is identical."
Same Technological Characteristics (design, materials, etc.)?	Yes. Stated as "Yes, the technological characteristics are exactly the same."
Descriptive Characteristics Precise Enough to Ensure Equivalence?	Yes.

Conclusion from the 510(k): Based on these criteria, the Catheter Repair Kit with Replacement Connector (HemoSplit Repair Kit) was deemed substantially equivalent to the predicate device (Catheter Repair Kit with Replacement Connector, K022561).

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

Sample Size for Test Set: Not applicable / Not mentioned. This 510(k) submission does not describe a separate "test set" in the context of performance evaluation with specific data points. The focus is on comparing the design and stated intended use to a predicate device.
Data Provenance: Not applicable / Not mentioned. No specific data is presented that would have a country of origin or be classified as retrospective/prospective.

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

Number of Experts: Not applicable / Not mentioned. As there is no specific "test set" described for performance evaluation, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable / Not mentioned. Without a test set and expert review, an adjudication method is not relevant to this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is not described or referenced in the 510(k) summary. The device is a physical repair kit, not an AI or imaging diagnostic tool where MRMC studies are common.
Effect Size of Human Readers Improve with AI vs. Without AI: Not applicable. (See above.)

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Not applicable. This device is a physical product (a repair kit), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI/software does not apply.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this 510(k) submission is the established performance and safety profile of the predicate device (Catheter Repair Kit with Replacement Connector, K022561). The new device demonstrates "substantial equivalence" to this known entity.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable / Not mentioned. This submission does not involve machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

How Ground Truth for Training Set Was Established: Not applicable / Not mentioned. (See above.)

Summary

{0}------------------------------------------------

K030442

JUL 2 1 2003

HemoSplit Repair Kit

it Repair Kit 510(k)

Section 5 Catheter Repair Kit with Replacement Connector 510(k)

Summary of Safety and Effectiveness Information 21 CFR 807.92

l. Submitter Information:

Submitter Name: Bard Access Systems, Inc. [Subsidiary of C. R. Bard, Inc.] Address: 5425 W. Amelia Earhart Drive Salt Lake City, UT 84116 Telephone Number: (801) 595-0700, Ext. 5525 Fax Number: (801) 595 5425 Contact Person: Glenn Norton Date of Preparation: February 10, 2003

2. Device Name:

Device Name: Trade Name: Common/Usual Name: Classification Name:

Catheter Repair Kit with Replacement Connector Catheter Repair Kit Catheter Repair Kit MSD Blood Access Device Accessory 21 CFR 876.5540 Class II Gastroenterology and Renal

Classification Panel:

3. Predicate Device Name:

Device Name: Trade Name: Common/Usual Name: Classification Name:

Catheter Repair Kit with Replacement Connector Catheter Repair Kit Catheter Repair Kit MSD Blood Access Device Accessory 21 CFR 876.5540, Class II Gastroenterology and Renal

Classification Panel:

4. Device Description

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

న. Intended Use

To replace: Cracked or broken female luer lock connectors or repair damaged extension leg where there is a minimum of 4.5 cm of viable extension tubing on the following catheters:

. Soft-Cell® Long-Term Dual Lumen Catheter
. Opti-Flow® Long-Term Dual Lumen Catheter
Slim-Cath™ Short-Term Dual Lumen Catheter .
Vaccess® Short-Term Single Lumen Catheter .
Flexxicon® Short-Term Dual Lumen Catheter .
. Niagara™ Short-Term Dual Lumen Catheter
Flexxicon® II Short-Term Dual Lumen Catheter .
HemoGlide™ Long-Term Dual Lumen Catheter .
HemoSplit™ Long-Term Hemodialysis Catheter .

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K030442

Page 2 of 2

510(k)

6. Technological Characteristics Summary:

6.1 Does the new device have the same indication statement?
No. A change to the indications is the subject of this submission. The change includes removal of the generic Vas-Cath® trade name and the addition of the trade name HemoSplit™ to the list of repairable catheters.
6.2 Do the differences alter the intended therapeutic/diagnostic/etc. effect? Deciding may consider impact on safety and effectiveness.
No, the intended use is the same. There is only the addition of a catheter trade name to the list of repairable catheters.
6.3 The new device has the same intended use and may be "Substantially Equivalent."
Yes, the intended use is identical.
6.4 Does the new device have the same technological characteristics, c.g. design, materials, etc. ?
Yes, the technological characteristics are exactly the same.
6.5 Are the descriptive characteristics precise enough to ensure equivalence?
Yes.

Conclusion:

Based on FDA's decision tree, the Catheter Repair Kit with Replacement Connector is substantially equivalent to the predicate device, Catheter Repair Kit with Replacement Connector, K022561, concurrence date January 23, 2002.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The symbol consists of three curved lines that form a wing-like shape, with a central figure that could be interpreted as a human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Mr. Glenn Norton Sr. Regulatory Affairs Specialist Bard Access Systems, Inc. C. R. Bard, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116

Re: K030442

Trade/Device Name: Catheter Repair Kit with Replacement Connector -(adding the HemoSplit® Catheter, 14.5 F x 19cm curved and 42 cm straight) Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 NFK Dated: June 27, 2003 Received: June 30, 2003

Dear Mr. Norton:

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.

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); 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO30442

HemoSplit Repair Kit 510(k)

Section 1-D

Catheter Repair Kit with Replacement Connector

510(k)

INDICATION(S) FOR USE STATEMENT*

I state in my capacity as Senior Regulatory Affairs Specialist of Bard Access Systems, that this notification [510(k)] for the following device, Catheter Repair Kits with Replacement Connectors, is indicated for the following:

To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell® Long-Term Dual Lumen Catheter, Opti-Flow® Long-Term Dual Lumen Catheter, Slim-Cath™ Short-Term Dual Lumen Catheter, Vaccess® Short-Term Single Lumen Catheter, Flexxicon® Short-Term Dual Lumen Catheter, Niagara™ Short-Term Dual Lumen Catheter, Flexxicon® II Short-Term Dual Lumen Catheter, HemoGlide™ Long-Term Dual Lumen Catheter, and HemoSplit™ Long-Term

Hemodialysis Catheter.

Signature of 510(k) Submitter:

Printed Name of Submitter:

Signature

Glenn Norton

Date:

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

2.10.2003

Concurrence of Office of Device Evaluation

510(k) Number

Division Sign-Off Office of Device Evaluation

Prescription Use

Over-The-Counter Use

Daniela Ingram

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Device

510(k) Number

000000

Regulation Number and Section

§ 876.5540 Blood access device and accessories.

(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.