(54 days)
Not Found
No
The description focuses on a mechanical suturing device and does not mention any AI/ML components or functionalities.
No.
The device is described as a suturing device intended for soft tissue approximation and/or ligation in general surgical procedures, and to aid in the prevention of suture needle stick injuries. It does not perform any therapeutic function on the patient's condition itself.
No
The device is described as a suturing device intended for soft tissue approximation and/or ligation in general surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components: a reusable instrument, a single-use disposable cartridge, a single-use disposable needle, and sutures. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue approximation and/or ligation in general surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a mechanical device that physically passes sutures through tissue. This is a surgical instrument, not a device that analyzes biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens obtained 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
The SuturTek Incorporated FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.
The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.
It is designed to aid in the prevention of accidental suture needle stick injuries.
Product codes (comma separated list FDA assigned to the subject device)
GAL, GAB, HCF
Device Description
The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.
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)
Tests applicable to the type of safety device and safety features of the FASTCLOSE Device per the FDA Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps Injury Prevention Features" (March 1995) were: Simulated Use Testing
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
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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
K030227 page 1/2
MAR 1 7 2003
SuturTek 51 Middlesex Street North Chelmsford Massachusetts 01863 (978)-251-8088
510K Summary of Safety and Effectiveness January 14, 2003 SuturTek FASTCLOSE™ Suturing Device
Sponsor Name SuturTek 51 Middlesex Street North Chelmsford Massachusetts 01863 (978)-251-8088 Contact Individual: Debbie Iampietro
-
- Device Name
Proprietary Name: FASTCLOSE™ Common/Usual Name: Suture Panel: General and Plastic Surgery Class II 878.4830, 878.4800 GAL, GAB, HCF
- Identification of Legally Marketed Device 3. The modified SuturTek FASTCLOSE™ Suturing Device is substantially equivalent to the SuturTek FASTCLOSE™ Suturing Device K011105.
Device Description 4.
The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.
1
K030227 Page 2/2
000052
న. Intended Use
The SuturTek Incorporated FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.
The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.
It is designed to aid in the prevention of accidental suture needle stick injuries.
- Comparison of Technological Characteristics 6. The proposed SuturTek FASTCLOSE™ Suturing Device and the currently marketed device:
Have the same intended use Both are intended for soft tissue approximation and/or ligation in general surgical procedures.
Use the same fundamental scientific technology
- Manual instrument passes a needle through tissue to place . sutures
- . Have the same components reusable instrument single-use, disposable cartridge single-use, disposable needle sutures
The differences between the proposed SuturTek FASTCLOSE™ Suturing Device, and the current SuturTek FASTCLOSE™ Suturing Device, K011105 are:
- 에 Added Sharps Injury Prevention Feature Claims
7. Performance Testing
Tests applicable to the type of safety device and safety features of the FASTCLOSE Device per the FDA Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps Injury Prevention Features" (March 1995) were: Simulated Use Testing
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2003
SuturTek Incorporated c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748
Re: K030227
Trade/Device Name: SuturTek FASTCLOSE™ Suturing Device Regulation Number: 21 CFR 878.4830 Regulation Name: Absorbable surgical gut suture Regulatory Class: II Product Code: GAL Dated: January 14, 2003 Received: January 22, 2003
Dear Ms. Iampietro:
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 - Ms. Debbie Iampietro
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
W 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
KO30 Jul 510(k) Number (if known):
SuturTek FASTCLOSE™ Suturing Device Device Name:
Indications For Use:
The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.
The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.
It is designed to aid in the prevention of suture needle stick injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use _____________
Muriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K030227
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