(111 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of PTFE pledgets, with no mention of AI or ML technologies.
No
Explanation: The device, PremiPatch PTFE Pledgets, is used to mechanically support sutures and aid in suture buttressing, which are supportive functions during surgical procedures rather than directly treating or curing a disease or condition. While used in a therapeutic context (surgery), the device itself is a mechanical aid, not a therapeutic agent.
No
The device description indicates that PremiPatch PTFE Pledgets are used to mechanically secure and support sutures and aid in suture buttressing in cardiovascular tissue. This is a supportive function during surgery, not a diagnostic one. Diagnostic devices are used to identify or analyze diseases or conditions.
No
The device description clearly states it is made of polytetrafluorothylene (PTFE) and is supplied as pre-cut sections, indicating a physical, hardware-based medical device.
Based on the provided information, the PremiPatch PTFE Pledgets are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas. This is a mechanical function performed in vivo (within the body) during surgery.
- Device Description: The description details a physical object (pre-cut sections of PTFE) used as a suture buttress. This is a surgical implant/accessory, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Anatomical Site: The device is used directly on cardiovascular tissue during surgery. IVDs typically analyze samples taken from the body.
In summary, the PremiPatch PTFE Pledgets are a surgical accessory used to aid in the mechanical support of sutures during cardiovascular procedures. This falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchyms, when a nonabsorbable suture is indicated. Pledgets are also used to aid in suture buttressing.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
The PremiPatch PTFE Pledgets are pre-cut sections of non-absorbable undyed polytetrafluorothylene (PTFE) which are supplied sterile. The PremiPatch PTFE Pledgets are used as a suture buttress for nonabsorbable sutures. The pledgets are available in two application styles: firm and soft and various shapes and sizes. Depending on the size they are available package two or six per pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular tissue
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 safety and performance of the PremiPatch PTFE Pledgets was evaluated through nonclinical testing. The non-clinical test data provided in this submission demonstrated that the PremiPatch PTFE Pledgets meet the performance specifications. The submission includes bench testing, including: flexibility and bridge rupture tests.
The biocompatibility evaluation that was previously conducted on the PTFE material for the pledgets cleared in the Optilene Nonabsorbable Surgical Suture (K133890) per ISO-10993. "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" is deemed supportive of the proposed device, PremiPatch PTFE Pledgets. There are no changes to the material composition and the manufacturing and sterilization processes are identical to the reference predicate, therefore, no additional biocompatibility testing was conducted.
The PremiPatch PTFE Pledgets are package in a peel pouch and sterilized by ethylene oxide. Accelerated aging data for the PremiPatch PTFE Pledgets has been generated to demonstrate package integrity and shelf life of the PremiPatch device.
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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
Aesculap, Inc. Ms. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K151865 Trade/Device Name: PremiPatch PTFE Pledget Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget made of Polypropylene, Polyethylene Terephthalate, or Polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: August 31, 2015 Received: August 31, 2015
Dear Ms. Racosky:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151865
Device Name PremiPatch PTFE Pledgets
Indications for Use (Describe)
PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas, when a non-absorbable suture is indicated. Pledgets are also used to aid in suture buttressing.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Page 1 of 2
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
PremiPatch PTFE Pledgets October 21, 2015
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky
610-984-9291 (phone)
610-791-6882 (fax)
kathy.racosky@aesculap.com |
| TRADE NAME: | PremiPatch PTFE Pledgets |
| COMMON NAME: | Intracardiac patch or pledget made of polytetrafluorothylene |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | Patch, Pledget and Intracardiac, Petp, Ptfe, Polypropylene |
| REGULATION NUMBER: | 870.3470 |
| PRODUCT CODE: | DXZ |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the PremiPatch PTFE Pledgets are substantially equivalent to: · PTFE Felts and Pledgets, Boston Scientific Corporation (K041716)
DEVICE DESCRIPTION
The PremiPatch PTFE Pledgets are pre-cut sections of non-absorbable undyed polytetrafluorothylene (PTFE) which are supplied sterile. The PremiPatch PTFE Pledgets are used as a suture buttress for nonabsorbable sutures. The pledgets are available in two application styles: firm and soft and various shapes and sizes. Depending on the size they are available package two or six per pouch.
4
INDICATIONS FOR USE
PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas, when a nonabsorbable suture is indicated. Pledgets are also used to aid in suture buttressing.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The PremiPatch PTFE Pledgets are substantially equivalent to other pledgets cleared by FDA. PremiPatch PTFE Pledgets are offered in the same styles and similar sizes. The subject device is shown to be substantially equivalent and has the same performance characteristics to the predicate devices through comparison in design, intended use, material and function with the exception of the packaging.
PERFORMANCE DATA
The safety and performance of the PremiPatch PTFE Pledgets was evaluated through nonclinical testing. The non-clinical test data provided in this submission demonstrated that the PremiPatch PTFE Pledgets meet the performance specifications. The submission includes bench testing, including: flexibility and bridge rupture tests.
The biocompatibility evaluation that was previously conducted on the PTFE material for the pledgets cleared in the Optilene Nonabsorbable Surgical Suture (K133890) per ISO-10993. "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" is deemed supportive of the proposed device, PremiPatch PTFE Pledgets. There are no changes to the material composition and the manufacturing and sterilization processes are identical to the reference predicate, therefore, no additional biocompatibility testing was conducted.
The PremiPatch PTFE Pledgets are package in a peel pouch and sterilized by ethylene oxide. Accelerated aging data for the PremiPatch PTFE Pledgets has been generated to demonstrate package integrity and shelf life of the PremiPatch device.
CONCLUSION:
Based on the nonclinical testing PremiPatch PTFE Pledgets have been demonstrated to be substantially equivalent to the predicate devices.