(28 days)
Not Found
Not Found
No
The device description and performance summary focus on the material properties and physical form of the PTFE Felts and Pledgets, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is used for tissue prosthesis and suture buttressing during surgery, not for treating a disease or health condition.
No
The device description and intended use indicate that the PTFE Felts and Pledgets are used for surgical procedures like tissue prosthesis and suture buttressing, which are therapeutic rather than diagnostic actions. They do not acquire or process data to provide information about a patient's health status.
No
The device description clearly states it is made from 100% polytetraflouroethylene fibers and describes physical manufacturing processes (heat setting, scouring, cutting, punching), indicating it is a physical medical 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 is for surgical procedures like ventricular aneurysmectomy, tissue prosthesis, and suture buttressing. These are all in vivo (within the living body) applications, not in vitro (outside the living body) diagnostic tests.
- Device Description: The device is a physical material (PTFE felt and pledgets) used for structural support and reinforcement during surgery. It does not involve analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological material to provide diagnostic information. The device's function is purely mechanical and supportive within the body.
Therefore, this device falls under the category of a surgical implant or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Felts: Indicated for Ventricular aneurysmectomy; tissue prosthesis, and suture buttressing.
Pledgets: Indicated for Tissue, prosthesis, and suture buttressing.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
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.
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)
The PTFE Felts and Pledgets have been tested. All data gathered has demonstrated that the device is Substantially Equivalent to the predicate device. No new issues of safety and efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PTFE Felts and Pledgets (Preamendment devices)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUL 2 2 2004
510(k) Summary
per 21 CFR §807.92
| Submitter's Name
and Address | Boston Scientific Corporation (BSC)
Two Scimed Place
Maple Grove, MN 55311 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Name: Maureen Montbriand
Title: Regulatory Affairs Specialist
Telephone: 763-494-2903
Facsimile: 763-494-2981
e-mail: montbrim@bsci.com |
| Date Prepared | June 23, 2004 |
| Proprietary
Name(s) | PTFE Felts and Pledgets |
| Common Name | Intracardiac patch or pledget made of polytetrafluoroethylene |
| Product Code | DXZ |
| Classification of
Device | Class II, 21 CFR Part 870.3470 |
| Predicate Device | PTFE Felts and Pledgets (Preamendment devices) |
| Device
Description | 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. |
| Intended Use of
Device | Felts:
Indicated for Ventricular aneurysmectomy; tissue prosthesis,
and suture buttressing. |
| | Pledgets: Indicated for Tissue, prosthesis, and suture
buttressing. |
| Summary of
Substantial
Equivalance | The PTFE Felts and Pledgets have been tested. All data
gathered has demonstrated that the device is Substantially
Equivalent to the predicate device. No new issues of safety and
efficacy have been raised. |
1
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.
2
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 |
| Indications | |
| For Use | Felts: |
| Indicated for Ventricular aneurysmectomy; tissue | |
| prosthesis, and suture buttressing. | |
| Pledgets: | |
| Indicated for Tissue, prosthesis, and | |
| suture 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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