(28 days)
Felts:
Indicated for Ventricular aneurysmectomy; tissue prosthesis, and suture buttressing.
Pledgets:
Indicated for Tissue, prosthesis, and suture buttressing.
The PTFE Felts and Pledgets are manufactured from 100% polytetraflouroethylene fibers. The felt is purchased from an outside supplier in bulk, which is then heat set, scoured and cut into squares, offering two sizes, or punched into oval, round, square or rectangular pledgets. The Felts have a nominal thickness of 1.245mm (0.049"). The Pledgets have a nominal thickness of either 0.99mm (0.039") or 1.245mm (0.049") depending upon size.
The provided document is a 510(k) summary for PTFE Felts and Pledgets and does not contain the acceptance criteria or refer to any study that proves the device meets specific performance criteria. This document primarily focuses on establishing substantial equivalence to a predicate device, which is a common pathway for medical device clearance in the US, especially for older or less complex devices.
Therefore, I cannot provide the requested information from this document.
Here's why and what's typically expected for a device where such information would be available:
- Type of Device: The PTFE Felts and Pledgets are described as surgical implants used for buttressing and tissue repair in cardiac procedures. These are generally considered low to moderate risk devices that rely on well-established material properties and manufacturing processes.
- Predicate Device Pathway: The 510(k) summary explicitly states its reliance on "Preamendment devices" as predicates. This means the device is being cleared because it is substantially equivalent to devices marketed before May 28, 1976 (the enactment date of the Medical Device Amendments) or to devices that have previously gone through the 510(k) process.
- Focus of the Document: The content of the 510(k) summary (and the FDA's letter) is on establishing this "substantial equivalence" based on similar intended use, indications for use, technological characteristics, and safety/efficacy profile to the predicate devices. It doesn't detail performance studies in the way you might expect for novel devices or those reliant on complex algorithms.
- "No new issues of safety and efficacy have been raised.": This statement, often found in 510(k) summaries for substantially equivalent devices, indicates that the manufacturer believes their device, being similar to previously cleared devices, does not introduce new risks or questions regarding its performance that would necessitate extensive new clinical or performance studies.
What you would typically see for devices requiring performance studies (e.g., AI/ML-enabled devices):
For a device that would have acceptance criteria and a study to prove it, especially an AI-enabled device, you would look for sections detailing:
- Performance Data: Often found under "Summary of Safety and Effectiveness" or a dedicated "Performance Data" section.
- Bench Testing: Mechanical properties, biocompatibility, durability, etc.
- Clinical Studies: If required, these would detail study design, patient population, endpoints, results, and statistical analysis.
- Software Validation/Verification: For AI-enabled devices, this would include details on the validation of the algorithm itself, addressing points 1-9 of your request.
In summary, as the provided document is a 510(k) summary for a legacy-type device cleared via substantial equivalence, it does not contain the detailed performance study information you are seeking.
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JUL 2 2 2004
510(k) Summary
per 21 CFR §807.92
| Submitter's Nameand Address | Boston Scientific Corporation (BSC)Two Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name andInformation | Name: Maureen MontbriandTitle: Regulatory Affairs SpecialistTelephone: 763-494-2903Facsimile: 763-494-2981e-mail: montbrim@bsci.com |
| Date Prepared | June 23, 2004 |
| ProprietaryName(s) | PTFE Felts and Pledgets |
| Common Name | Intracardiac patch or pledget made of polytetrafluoroethylene |
| Product Code | DXZ |
| Classification ofDevice | Class II, 21 CFR Part 870.3470 |
| Predicate Device | PTFE Felts and Pledgets (Preamendment devices) |
| DeviceDescription | The PTFE Felts and Pledgets are manufactured from 100%polytetraflouroethylene fibers. The felt is purchased from anoutside supplier in bulk, which is then heat set, scoured and cutinto squares, offering two sizes, or punched into oval, round,square or rectangular pledgets. The Felts have a nominalthickness of 1.245mm (0.049"). The Pledgets have a nominalthickness of either 0.99mm (0.039") or 1.245mm (0.049")depending upon size. |
| Intended Use ofDevice | Felts:Indicated for Ventricular aneurysmectomy; tissue prosthesis,and suture buttressing. |
| Pledgets: Indicated for Tissue, prosthesis, and suturebuttressing. | |
| Summary ofSubstantialEquivalance | The PTFE Felts and Pledgets have been tested. All datagathered has demonstrated that the device is SubstantiallyEquivalent to the predicate device. No new issues of safety andefficacy have been raised. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2004
Boston Scientific Corporation c/o Ms. Maureen Montbriand Regulatory Affairs Specialist Two Scimed Place B220 Maple Grove, MN 55311-1566
Re: K041716 PTFE Felts and Pledgets Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: Class II Product Code: DXZ Dated: June 23, 2004 Received: June 24, 2004
Dear Ms. Montbriand:
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 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. Maureen Montbriand
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,
Dina R. Vahner
Image /page/2/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is likely from a document or other official paper.
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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Indications for Use
| 510(k) Number(if known) | Preamendment device |
|---|---|
| Device Name | PTFE Felts and Pledgets |
| IndicationsFor Use | Felts:Indicated for Ventricular aneurysmectomy; tissueprosthesis, and suture buttressing. |
| Pledgets:Indicated for Tissue, prosthesis, andsuture buttressing. |
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Wehner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K041716
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§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).