(119 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a surgical suture, with no mention of AI or ML technologies.
No
The device is a surgical suture used for superficial skin closure, which is a restorative rather than therapeutic function.
No
The device is a surgical suture used for skin closure, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical surgical suture made of stainless steel with barbs and a backstop, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description and Intended Use: The "Fast Throw" Stainless Steel Surgical Suture is a device used directly on the human body for superficial skin closure. It is a physical device used in a surgical procedure, not for testing biological samples.
The information provided clearly describes a surgical suture, which is a therapeutic device used to repair tissue, not a diagnostic device used to analyze samples.
N/A
Intended Use / Indications for Use
The "Fast Throw" Stainless Steel Surgical Suture is indicated for use in superficial skin closure.
Product codes (comma separated list FDA assigned to the subject device)
FZP, GAQ
Device Description
The Advanced Surgical Products "Fast Throw" Stainless Steel Surgical Suture is a sterile single use knot-less suture that is primarily designed for skin wound closure The device incorporates barbs along the length of the suture and works in conjunction with a Tshaped backstop incorporated at the proximal end of the device. As the suture is passed through the wound, the wound is cinched up to the T-shaped backstop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superficial skin
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)
Per USP Standards, needle attachment pull strength was performed as well as tensile testing on sterilized sutures.
In Vivo testing was performed with sterilized, packaged sutures in a controlled environment.
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.
K933686, K931271, K931915, K970793
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
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K030926/P1/2
JUL 2 1 2003
IV. Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
510(k) Number: TBD
Applicant Information:
| Date Prepared: | March 10, 2003 |
|---|---|
| Name: | |
| Address: | Advanced Surgical Products |
| 681 Manzanita Ave | |
| Sunnyvale, CA. 94085 | |
| Contact Person: | |
| Phone Number: | Jeffrey S. Jones |
| 650-207-6987 |
408-734-5316
Device Information:
Facsimile Number:
| Classification: | Class II |
|---|---|
| Trade Name: | Advanced Surgical Products, Inc. "Fast Throw" Suture |
| Common name: | STAINLESS STEEL SURGICAL SUTURE |
Predicate Device:
The Advanced Surgical Products "Fast Throw" Stainless Steel Surgical Suture is substantially equivalent in intended use and method of operation to the following predicate devices:
| Name: | LOOK Inc. 316L STAINLESS STEEL SURGICAL SUTURE |
|---|---|
| Manufacture: | LOOK, Inc. |
| 510(k) #: | K933686 |
| Name: | ETHI-PACK SURGICAL STAINLESS STEEL SUTURE |
| Manufacture: | ETHICON, Inc. |
| 510(k) #: | K931271 |
| Name: | STAINLESS STEEL SUTURE |
| Manufacture: | SURGIMETRICS INTERNATIONAL, LTD. |
| 510(k) #: | K931915 |
1
K030926/P2/2
Name: Manufacture: 510(K) #:
CLIP, IMPLANTABLE UNITED STATES SURGICAL K970793
Device Description:
The Advanced Surgical Products "Fast Throw" Stainless Steel Surgical Suture is a sterile single use knot-less suture that is primarily designed for skin wound closure The device incorporates barbs along the length of the suture and works in conjunction with a Tshaped backstop incorporated at the proximal end of the device. As the suture is passed through the wound, the wound is cinched up to the T-shaped backstop.
Intended Use:
The "Fast Throw" Stainless Steel Surgical Suture is indicated for use in superficial skin closure.
Comparison to Predicate Devices:
The "Fast Throw" Stainless Steel Surgical Suture is substantially equivalent in intended use and method of operation to 316L monofilament Stainless Steel sutures and Implantable Clips currently in use.
Pre-Clinical Data:
Per USP Standards, needle attachment pull strength was performed as well as tensile testing on sterilized sutures.
In Vivo testing was performed with sterilized, packaged sutures in a controlled environment.
Summary:
Based on the product technical information, intended use, performance and biocompatibility information provided in this pre-market notification, Advanced Surgical Products, Inc. "Fast Throw" Stainless Steel Surgical Suture has been shown to be substantially equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of three stylized, overlapping shapes that resemble abstract human figures or birds in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Mr. Jeffrey S. Jones President Advanced Surgical Products 681 Manzanita Avenue Sunnyvale, California 94085
Re: K030926
Trade/Device Name: "Fast Throw" Stainless Steel Surgical Suture Regulation Number: 21 CFR 878.4300, 878.4495 Regulation Name: Implantable clip, Stainless steel suture Regulatory Class: II Product Code: FZP, GAQ Dated: May 22, 2003 Received: May 27, 2003
Dear Mr. Jones:
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.
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.
3
Page 2 - Mr. Jeffrey S. Jones
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) 594-4659. 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko30926
II. Indications for Use Form
510(k) number (if known):
Device Name:
Advanced Surgical Products, Inc. "Fast Throw" Stainless Steel Surgical Suture
Indications for Use:
The "Fast Throw" Stainless Steel Surgical Suture is indicated for use in superficial skin closure.
Muriàm C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030926