(261 days)
Not Found
No
The summary describes a mechanical suture passer and contains no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used for the placement of sutures for soft tissue approximation in surgical procedures, which is a therapeutic intervention.
No
The device description states it is "designed to pass either one or both needles of a double armed suture through tissue for the creation of interrupted stitches," indicating it is a surgical tool for performing a procedure, not for diagnosing a condition.
No
The device description clearly states it is a "suture passer," which is a physical instrument used in surgery, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the placement of sutures in surgical procedures for soft tissue approximation. This is a surgical tool used directly on the patient's body.
- Device Description: The description confirms it's a suture passer, a mechanical device for handling sutures during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the Auto Suture* SurgiStitch** suture passer is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Auto Suture* SurgiStitch** suture passer is indicated for the placement of interrupted sutures for soft tissue approximation in surgical procedures such as cardiovascular and gastrointestinal surgery.
Product codes
GAT
Device Description
The Auto Suture* SurgiStitch** suture passer is designed to pass either one or both needles of a double armed suture through tissue for the creation of interrupted stitches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
REG CLIN AFFAIRS USSC APR-24-98 FRI 10:38 AM
APR 2 5 1998
510(k)_Summary of Safety and Effectiveness IX.
SUBMITTER:
United States Surgical Corporation 150 Glover Avenue Norwalk, CT 06856
Victor M. Clavelli CONTACT PERSON:
April 24, 1998 DATE PREPARED:
CLASSIFICATION NAME: Manual Surgical Instrument for General Use
Suture Passer COMMON NAME:
Not Yet Determined PROPRIETARY NAME:
PREDICATE DEVICES: Modified Endoscopic Suturing ** device K961173
The Auto Suture* SurgiStitch** suture passer is designed DEVICE DESCRIPTION: to pass either one or both needles of a double armed suture through tissue for the creation of interrupted stitches.
The Auto Suture* SurgiStitch** suture passer is indicated INTENDED USE: for the placement of interrupted sutures for soft tissue in surgical procedures approximation such as cardiovascular and gastrointestinal surgery.
MATERIALS: Like all devices manufactured by U.S. Surgical Corporation, the Auto Suture* SurgiStitch** suture passer is composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 1998
Mr. Victor Clavelli United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
K972911 Re:
Trade Name: Auto Suture SurgiStitch suture passer Regulatory Class: II Product Code: GAT Dated: March 11, 1998 Received: March 12, 1998
Dear Mr. Clavelli:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in
2
Page 2 - Mr. Clavelli
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
-
- The labeling, packaging and method of sterilization of the suture cannot be changed without prior notification, review and clearance by FDA.
-
- The supplier of the sutures used in your device cannot be changed without prior notification, review and clearance by FDA.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
3
FAX NO. 203 845 4503
Image /page/3/Picture/3 description: The image shows a series of bold, black numbers against a white background. The numbers appear to be "492411". The numbers are somewhat stylized, with thick strokes and distinct shapes, making them easily readable despite the bold font.
Indications for Use:
510(k) Number (If known): __K972911
Device Name: Auto Suture* SurgiStitch** suture passer
t.
Indications for Use:
The Auto Suture* SurgiStitch** suture passer is indicated for the placement of interrupted sutures for soft tissue approximation in surgical procedures such as cardiovascular and gastrointestinal surgery.
(Please do not write below this line - continue on other page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use; Per 21 CFR 801.109
Over-The-Counter Use:
b. Oul
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
- Trademark of United States Surgical Corporation ** Trademark not yet determined