The adapters are used in connecting oxygenators, reservoirs, filters, tubing, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support.

The adapters are of the following generic types: straight adapters with or without luer locking mechanisms (male and female), large bore adapters, three-way connectors, and four-way connectors.

The materials used in the manufacturing of these adapters includes polycarbonate, acrylic, and Acrylonitrile-Butadiene-Styrene (ABS). The cleared Medtronics adapters are comprised of plexiglas and Note: polyvinyIchloride.

AI/ML Overview

The provided text describes a 510(k) submission for medical device adapters, focusing on demonstrating substantial equivalence to previously cleared devices rather than a typical performance study with acceptance criteria and reported metrics for a new, innovative device.

Therefore, the requested information elements (1-9) which typically relate to a performance study for a novel device, are not directly applicable or available in this document.

Instead, the document highlights:

Intended Use: The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.
Device Description: Various generic types of adapters (straight, large bore, three-way, four-way) made from polycarbonate, acrylic, and ABS.
Substantial Equivalence Claim: The adapters are substantially equivalent in intended use, design, technology, principles of operation, materials, and performance to the cleared Medtronics "Y" adapter (K790563) and Medtronics 3/16″ Large Bore Male adapter (K830728).
Validation of Safety Aspects:
- Sterilization conditions validated according to AAMI guidelines to achieve a Sterility Assurance Level (SAL) of 10-6.
- Ethylene oxide residuals will not exceed maximum limits.
- Blood contacting materials tested for biocompatibility according to FDA General Program Memorandum #G95-1 (ISO-10993 Part 1) for External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours).
- Expiration dating controlled by the shortest expiry component in a kit or two years, whichever is shorter.

The core of this submission is the argument that differences in design and materials raise no new issues of safety and effectiveness, and that the performance is substantially equivalent to the predicate devices. There is no independent performance study described with specific acceptance criteria in terms of clinical metrics (e.g., accuracy, sensitivity, specificity) for this type of component.

To directly answer your numbered points:

A table of acceptance criteria and the reported device performance: Not applicable. The "acceptance criteria" here are demonstrating substantial equivalence and meeting safety standards (sterilization, biocompatibility, residuals), not achieving specific performance metrics in a clinical trial. The "reported device performance" is essentially that it performs equivalently to the predicate devices and meets safety standards.
- Acceptance Criteria for Substantial Equivalence:
  - Intended use is the same as the predicate device.
  - Technological characteristics are the same as the predicate device, OR technological characteristics are different but do not raise new questions of safety and effectiveness, AND the device is as safe and effective as the predicate device.
- Reported Device Performance (based on 510(k) claim):
  - Performance is "substantially equivalent" to Medtronics adapters.
  - Sterilization: SAL of 10-6 achieved.
  - Ethylene oxide residuals: Will not exceed maximum limits.
  - Biocompatibility: Blood contacting materials found to be biocompatible per ISO-10993.
  - Expiration dating: Controlled by shortest expiry component or two years.
Sample sized used for the test set and the data provenance: Not applicable. No test set for performance comparison in the traditional sense is described. The "testing" refers to safety validations (sterilization, biocompatibility).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of submission relies on established safety guidelines and direct comparison to predicate devices, not expert-adjudicated ground truth for a test set.
Adjudication method: Not applicable.
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: Not applicable. This document is not about AI assistance or human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (adapters), not an algorithm.
The type of ground truth used: For safety aspects, the ground truth is established by recognized standards (AAMI, FDA GPM #G95-1, Federal Register regulations) for sterilization, residuals, and biocompatibility. For "performance," the ground truth is the established performance of the predicate devices.
The sample size for the training set: Not applicable. No training set for an algorithm is involved.
How the ground truth for the training set was established: Not applicable.

Summary

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NOV I n 1999

Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K992906'. The characters are written in a bold, slightly rough style, giving them a distinct and somewhat informal appearance. The contrast between the characters and the background is high, making the sequence easily readable.

Section II

Summary of Safety and Effectiveness Information Pertaining To Substantial Equivalence

Device Common Name:	Adapters
Classification Name:	Adapter, Stopcock, Manifold, Fitting,Cardiopulmonary Bypass

Intended Use:

The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.

Device Description:

The adapters are used in connecting oxygenators, reservoirs, filters, tubing, and other cardiopulmonary bypass components into circuits used in surgical procedures requiring extracorporeal support.

The adapters are of the following generic types: straight adapters with or without luer locking mechanisms (male and female), large bore adapters, three-way connectors, and four-way connectors.

Substantial Equivalence:

The adapters presented in this 510(k) are substantially equivalent in intended use, design, technology and principles of operation, materials and performance to the cleared Medtronics "Y" adapter (K790563) and the Medtronics 3/16″ Large Bore Male adapter (K830728).

Principle of Operation/Technology:

The adapters presented in this submission perform under the same principles as the cleared Medtronics components. Each is used to interconnect cardiopulmonary bypass components to provide a pathway for blood and other extracorporeal fluids.

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Section II

Design/Materials:

Differences in design and materials between the adapters indicated in this submission and the cleared Medtronics adapters raise no new issues of safety and effectiveness.

Performance:

The performance of the adapters presented in this submission is substantially equivalent to the performance of the Medtronics adapters.

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Section II

Additional Safety Information

Sterilization conditions have been validated in accordance with AAMI quidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits imposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).

Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) contact duration]. The blood contacting materials were found to be biocompatible.

The expiration dating of the submitted components is controlled by the component with the shortest expiry that is included in a kit, or two years; whichever is the shortest duration.

Conclusion

The convenience kit components submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared devices indicated within. Differences between the submitted adapters and the cleared adapters do not raise any new issues of safety or effectiveness.

Olson Medical Sales' statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended to be the basis for a patent infringement action.

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Section II

Summary of Safety and Effectiveness Information Pertaining To Substantial Equivalence

This Summary of Safety and Effectiveness was prepared on August 9, 1999.

Fax: 508-881-4858

This Summary was prepared by:	Garry A. CourtneyRegulatory Affairs Specialist
This Summary was prepared for:	OLSON MEDICAL SALES28 Howe StreetAshland, MA 01721Phone: 508-881-2250

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with two snakes coiled around it.

NOV 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olson Medical Sales, Inc. Mr. Garry A. Courtney Requlatory Affairs Association Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re : K992906 Components For Cardiovascular Procedure Kit Regulatory Class: II (TWO) Product Code: 74 DTL Dated: August 23, 1999 Received: August 30, 1999

Dear Mr. Courtney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Garry A. Courtney

This letter will allow you to beqin marketinq your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. bugdon for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Components For Cardiovascular Procedure Kit Device Name:

Indications For Use:

The Adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.

Garry A. Courtney Regulatory Affairs Associate Terumo Medical Corporation

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

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Kylie L. Kumpera

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number * 992906

00 4

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.