(72 days)
Not Found
No
The device description and intended use are purely mechanical components for connecting tubing, with no mention of any computational or analytical functions that would involve AI/ML.
No
The device is described as an adapter used to interconnect tubing and other devices during cardiopulmonary bypass procedures, which are used in surgical procedures requiring extracorporeal support. It facilitates the connection but does not directly treat or diagnose a disease or condition.
No
The device description indicates adapters for connecting components in cardiopulmonary bypass circuits, which are used for treatment and support, not for diagnosis.
No
The device description explicitly states the adapters are made of physical materials (polycarbonate, acrylic, ABS) and are used to connect physical components (tubing, oxygenators, etc.) in a cardiopulmonary bypass circuit. This indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the adapters are used "to interconnect tubing and other devices during cardiopulmonary bypass procedures." This is a surgical procedure performed on a patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The description details how the adapters connect components in a cardiopulmonary bypass circuit, which is an extracorporeal support system used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.), detect analytes, or provide diagnostic information based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical connection within a surgical circuit.
N/A
Intended Use / Indications for Use
The adapters are intended to be used to interconnect tubing and other devices during cardiopulmonary bypass procedures.
Product codes
74 DTL
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance:
The performance of the adapters presented in this submission is substantially equivalent to the performance of the Medtronics adapters.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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.
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.
1
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.
2
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.
3
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. Courtney
Regulatory Affairs Specialist |
|--------------------------------|-----------------------------------------------------------------------------------|
| This Summary was prepared for: | OLSON MEDICAL SALES
28 Howe Street
Ashland, MA 01721
Phone: 508-881-2250 |
.
4
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.
5
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
6
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)
OR
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