(56 days)
Not Found
No
The summary describes a passive implantable surgical patch and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as "Peri-Strips Staple Line Reinforcement" and is intended for "surgical repair of soft tissue deficiencies" and "reinforcement of staple lines" during various surgical procedures, which are therapeutic interventions.
No
Explanation: The device is described as a surgical prosthesis used for reinforcing staple lines during various surgical procedures, not for identifying or diagnosing medical conditions.
No
The device description explicitly states it is an "implantable surgical patch comprised of crosslinked bovine pericardium," which is a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant used to reinforce staple lines during various surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as an "implantable surgical patch comprised of crosslinked bovine pericardium." This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Peri-Strips is intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Product codes (comma separated list FDA assigned to the subject device)
DXZ
Device Description
An implantable surgical patch comprised of crosslinked bovine pericardium
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, lung, bronchus, gastric, small bowel, mesentery, colon, colorectal, left atrial appendage
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)
Not Found
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.
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
510(k) SUMMARY
- Synovis Surgical Innovations Submitted by: A Division of Synovis Life Technologies, Inc. 2575 University Ave. W. St. Paul, MN 55114 Tel: 651-603-3700 Fax: 651-603-5211
- Angela Mallery Contact Person: At address above
- Peri-Strips® Device Trade Name: Staple Line Reinforcement — Sleeve Configuration Peri-Strips® Staple Linc Reinforcement – Strip Configuration Peri-Strips® Dry Staple Linc Reinforcement
- Surgical Mesh Common Name:
- Intracardiac patch or pledget made of polypropylene, Classification Name: polyethylene terephthalate, or polytetrafluoroethylene
- Peri-Strips® Staple Line Reinforcement (Synovis Surgical Predicate device: Innovations, a division of Synovis Life Technologies, Inc.) K983162 CV Peri-Guard Cardiovascular Patch (Synovis Surgical Innovations, a division of Synovis Life Technologies, Inc.) K983602
- An implantable surgical patch comprised of crosslinked Device Description: bovine pericardium
1
| Statement of
Intended use: | Peri-Strips Staple Line Reinforcement is intended for use
as a prosthesis for the surgical repair of soft tissue
deficiencies using surgical staplers when staple line
reinforcement is needed. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Peri-Strips can be used for reinforcement of staple lines
during lung and bronchus resections and during bariatric
surgical procedures. |
| | Peri-Strips can be used for reinforcement of staple lines
during gastric, small bowel, mesentery, colon, and
colorectal procedures. |
| | Peri-Strips is intended to be used for reinforcement of suture-
lines and staple-lines (i.e., occlusion of the left atrial
appendage during open chest procedures) during cardiac
surgery. |
| Technological
Comparisons: | Peri-Strips® Staple Line Reinforcement is substantially
equivalent to the predicate device, having the same
technological characteristics. |
| Testing: | Peri-Strips® Staple Line Reinforcement is substantially
equivalent to the predicate device in term of testing and
indications for use. |
2
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other, with a wavy line underneath them.
APR 1 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synovis Surgical Innovations c/o Ms. Angela Mallery Regulatory Affairs Manager 2575 university Avenue W. St. Paul, MN 55114-1024
Re: K040415
Peri-Strips Staple Line Reinforcement Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget Regulatory Class: Class II (two) Product Code: DXZ Dated: February 20, 2004 Received: February 18, 2004
Dear Ms. Mallery:
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.
3
Page 2 - Ms. Angela Mallery
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. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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. Buchner
Bram
Director
Divisi
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040415
Device Name:
Indications For Use:
Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Peri-Strips is intended to be used for reinforcement of suturelines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
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)
Duana P. Voelkel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K040415