The Chase Medical Femoral Access Cannulation Set is intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Chase Femoral Access Cannulation Set. The cornerstone of the submission is the claim of substantial equivalence to an existing predicate device, the RMI Femoral Access Cannulation Set (K891576). Therefore, the study proving the device meets acceptance criteria is not a typical performance study with defined acceptance criteria and statistical analysis, but rather a direct comparison demonstrating identical characteristics to the predicate device.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance	Study/Evidence
Identical Physical Form	Identical to RMI device	Direct component comparison; supplied by same vendor.
Identical Material Composition	Identical to RMI device	Direct component comparison; supplied by same vendor.
Identical Functional Characteristics	Non-differentiable from RMI device	Direct component comparison; supplied by same vendor.
Equivalent Sterilization Process	100% EtO (same as predicate)	Chase Medical's sterilization information (Section 7).
Biocompatibility	Identical materials to predicate device	Section 5 of submission.
Packaging Integrity	Validated after sterilization, simulated transportation, and two-year accelerated heat aging.	Section 6 of submission.
Two-year Expiration Date	Labeled with a two-year expiration date.	Section 6 of submission.

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

Sample Size: Not applicable in the traditional sense of a "test set" for a performance study. The "test set" is essentially the Chase Femoral Access Cannulation Set itself, compared directly to the RMI predicate device. No statistical sample size for performance evaluation is mentioned.
Data Provenance: The comparison is based on the design, materials, and manufacturing specifications of both the Chase Medical device and the RMI device, which are claimed to be identical. The RMI device has been marketed worldwide for 6 years (retrospective information about the predicate). The Chase device implicitly uses prospective validation for packaging integrity.

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

Not applicable. The "ground truth" for this submission is established by the identity of the components and manufacturing processes between the new device and the predicate device, as supplied by the same vendor. No independent expert panel was involved in establishing a "ground truth" for a performance test.

4. Adjudication Method for the Test Set

Not applicable. There's no performance "test set" requiring adjudication in the context of clinical outcomes or diagnostic accuracy. The adjudication is essentially the FDA's review of the documentation supporting the claim of substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not a diagnostic imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (cannulation set), not an algorithm or AI system. Its performance is inherent to its physical characteristics and functionality, not a computational output.

7. The Type of Ground Truth Used

The "ground truth" is the demonstrated identity (physical form, material composition, functional characteristics, sterilization, biocompatibility, packaging) between the Chase Medical Femoral Access Cannulation Set and its predicate device, the RMI Femoral Access Cannulation Set. This is a technical and manufacturing "ground truth" rather than a clinical or diagnostic one.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of this 510(k) submission.

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

Not applicable, as there is no training set.

Summary

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K972993

MAR 3 1 1998

August 11, 1997

Food and Drug Administration Center for Device and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850

Re: 510(k) Summary

Document Control Clerk Attention:

This document is to notify you of the intention of Chase Medical Inc. to manufacture and market the following device.

Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Classification Name:

Common / Usual Name: Femoral Access Cannulation Set

CHASE FEMORAL ACCESS CANNULATION SET Proprietary Name:

Establishment Registration Number: 9028011

Classification: Femoral Access Cannulation Sets are reviewed by the FDA Cardiovascular (CV) Classification Panel. The Product Classification Code and number for the predicate device and this device is 74DWF. According to the classification code, this is a class two device.

Performance Standards: None

Manufacturing Site: 1876 Firman Dr. Richardson, TX 75081

Sterilization Site: Steritec Inc. , Athens TX

Intended Use:

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Substantial Equivalence:

RMI has marketed a Femoral Access Cannulation Set (K891576) worldwide for 6 years. The CHASE Femoral Access Cannulation Set is an exact duplicate of the RMI Femoral Access Cannulation Set, model number FEM-020.

BASIS

The CHASE device and the RMI device have identical physical form, material composition and functional characteristics. Each component is supplied by the EXACT SAME VENDOR (Angeion Corporation, Plymouth, MN) WITH IDENTICAL SPECIFICATIONS. Section 2 contains a Substantial Equivalence Chart.

STERILIZATION

Sterilization of both catheters is conducted using 100% EtO. Section 7 contains Chase Medical's sterilization information.

PERFORMANCE

The performance characteristics of the CHASE catheters compared with the RMI device are non-differentiable. This can be expected considering that the two devices are the exact same product. Please see Section 6.

BIOCOMPATIBILITY

All materials used in the CHASE device are identical to those used in the predicate device. Please see section 5.

PACKAGING

Both devices are packaged in Tyvek / Polymylar pouches. Packaging integrity for the CHASE device is validated after packaged samples are subjected to sterilization, simulated transportation, and two year accelerated heat aging. The CHASE device will be labeled with a two year expiration date. Please see Section 6.

LABELING AND ASSEMBLY DRAWING

All proposed labeling and assembly drawings can be found in Section 3.

In accordance with requirements of the final rule for summaries addressed by the SMDA 1990, Section 8 contains a summary of the safety and effectiveness information upon which the substantial equivalence is based.

If you have any questions pertaining to this submission, please contact me at 972-783-0644.

Sincerely,

Bert Davis President

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bert Davis President Chase Medical, Inc. 1876 Firman Drive Richardson, TX 75081

MAR 3 1 1998

Re : K972993 Chase Femoral Access Cannulation Set Regulatory Class: II (Two) Product Code: DWF Dated: December 23, 1997 December 31, 1997 Received:

Dear Mr. Davis:

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 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, Druq, 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 Requlation (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 requlation 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 requlations.

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Page 2 - Mr. Bert Davis

This letter will allow you to begin marketing your device as described in your 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 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. CallaMan, Ph.D. 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): K972993

Device Name: Chase femoral Access Cannulatimfet

Indications For Use:

CHASE MEDICAL INC.

FEMORAL ACCESS CANNULATION SET

Intended Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bate R. Cooper a

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1697299 510(k) Number .

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).