(15 days)
The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the IS-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA to Guidant Corporation regarding the IS-1 Hemostasis Valve. This type of document is a regulatory approval and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, MRMC studies, etc.) that would typically be associated with performance evaluation of a device, especially an AI/ML medical device.
The letter explicitly states: "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..."
This means the device (IS-1 Hemostasis Valve) was approved based on its substantial equivalence to existing predicate devices, not on a new, comprehensive performance study with the kind of metrics you've requested. The 510(k) process for such devices relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, I cannot extract the information you've requested from this document because it is not present within this regulatory approval letter. The document does not describe acceptance criteria for performance, detailed study designs, sample sizes for training or test sets, expert qualifications, or the use of AI/ML algorithms.
In summary, none of the requested information can be provided based on the given document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Guidant Corporation c/o Ms. Colleen McCarter Bloom 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K031398
IS-1 Hemostasis Valve, Model 6799 Regulation Number: 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: May 2, 2003 Received: May 5, 2003
Dear Ms. McCarter Bloom:
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. Iisting 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 such 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.
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Page 2 - Ms. Colleen McCarter Bloom
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. 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 (301) 594-4646. 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 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE STATEMENT
| 510(k) Number(If known) | |
|---|---|
| Device Name | IS-1 Hemostasis Valve |
| Indications forUse | The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a sealaround the IS-1 lead terminal pin while flushing the lead lumen and/or duringintroduction/withdrawal of interventional devices. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
XQeartu
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K03134
Hemostasis IS-1 Valve Special 510K Guidant Corporation May 2003
§ 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.