(72 days)
Not Found
No
The device description and performance studies focus on the physical properties and conformance to USP standards of a traditional surgical suture, with no mention of AI or ML.
No
The device is a surgical suture used for tissue approximation and ligation, which is a supportive role in healing, not a therapeutic treatment itself.
No
The device, CATGUT, is described as an absorbable, sterile, flexible thread intended for use in soft tissue approximation and/or ligation. This is a surgical tool, not a device that identifies or monitors a medical condition or disease.
No
The device description clearly states it is a physical thread prepared from animal tissue, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which is a surgical procedure performed on the body, not on a sample taken from the body.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off blood vessels during surgery. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAL
Device Description
CATGUT, 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 and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. CATGUT meets the United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures. It will be offered uncoated or coated with glycerol and with or without standard needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, ophthalmic
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)
Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture.
Clinical Testing: Not available at the present time.
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
FEB 4 2000
T.CAD International 990930/MG-510(k) CATGUT
SECTION III
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and Title 21 CFR $807.92
A. Applicant & Submitted By:
Trading Consultants And Distributors International Inc. (T.CAD International) 157 WindDance Dr. Chicago, IL 60046-6681 Telephone: (847) 265-7676 Fax. : (847) 265-7686 Contact Person: Main M. Ghazal, President October 2nd 1999. Date Prepared:
B. Device Name:
- Trade Name: PLAIN/CHROMIC CATGUT a.
- Common or Usual Name: Absorbable Surgical Gut Sutures, Plain & Chromic ﻓ
- Classification Name: Absorbable surgical gut Suture. (Per 21CFR878.4830) C.
C. Predicate Device:
Plain and Chromic Absorbable Surgical Sutures of Davis & Geck (K930589) SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck)
D. Device Description:
CATGUT, 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 and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. CATGUT meets the United States Pharmacopeia (U.S.P.) standards for Absorbable Surgical Sutures. It will be offered uncoated or coated with glycerol and with or without standard needles attached.
E. Intended Use:
CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
1
1944002
T.CAD International 990930/MG-510(k) CATGUT
F. Comparison to Predicate Device:
| CATGUT | Predicate Device | |
|---|---|---|
| Intended Use | CATGUT is indicated for use in | |
| general soft tissue approximation | ||
| and/or ligation, including use in | ||
| ophthalmic procedures, but not for | ||
| use in cardiovascular and | ||
| neurological procedures. | Is indicated for use in general soft | |
| tissue approximation and/or | ||
| ligation, including use in | ||
| ophthalmic procedures, but not for | ||
| use in cardiovascular and | ||
| neurological procedures. | ||
| Suture Material | Absorbable, flexible thread | |
| prepared from either the serosal | ||
| connective tissue layer of beef | ||
| (bovine) or the submucosal fibrous | ||
| tissue of sheep (ovine) intestine | Absorbable, flexible thread | |
| prepared from either the serosal | ||
| connective tissue layer of beef | ||
| (bovine) or the submucosal fibrous | ||
| tissue of sheep (ovine) intestine | ||
| Suture | ||
| Characteristics | Factors which can affect tensile | |
| strength loss and absorption rates | ||
| are: | ||
| a. Type of suture-Plain gut | ||
| generally is expected to | ||
| absorb more rapidly than | ||
| chromic gut. | ||
| b. Infection-Surgical gut is | ||
| absorbed more rapidly in | ||
| infected tissue than in non- | ||
| infected tissue. | ||
| Tissue Sites-Surgical gut will | ||
| absorb more rapidly in tissue | ||
| where increased levels of | ||
| proteolytic enzymes are | ||
| present, as in the secretions | ||
| exhibited in the stomach, cervix | ||
| and vagina. | Same | |
| Sterilization Method | Gamma Irradiation | Same or equivalent method |
| How Supplied | Sterile and undyed. Offered for | |
| Single Use Only with or without | ||
| surgical needles. Also offered | ||
| uncoated or coated with glycerol. | Same or equivalent manner. | |
| SOFTGUT® is offered coated | ||
| with glycerol. | ||
| Suture Diameter, | ||
| Suture Length, | ||
| Knot Pull Tensile | ||
| Strength and Needle | ||
| Attachment Strength | Meet U.S.P. Requirements | Meet U.S.P. Requirements |
| Packaging | Packaged with an alcohol solution | |
| in Aluminum Foil and Polyester | ||
| tear open packaging. | Same or equivalent manner. | |
| Labeling | In conformance with CDRH | |
| instructions of the “Medical | ||
| Device Quality Manual” dated | ||
| December 1996. Package Inserts | ||
| in accordance with the FDA | ||
| Guidance documents “Alternate | ||
| Suture Labeling” Resulting from | ||
| the January 11th 1993 meeting with | ||
| HIMA, reformatted on December | ||
| 17th 1997. | Same |
2
T.CAD International 990930/MG-510(k) CATGUT
G. Clinical & Non-Clinical Testing:
Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture.
Clinical Testing: Not available at the present time.
H. Conclusion:
Based on the technological characteristics and physical properties of the device. the device description, the intended use of the device, and conformance with voluntary performance standards like:
- a. United States Pharmacopeia Standards
- b. ISO 9002, EN 46002 & EN 552 Standards
- c. FDA Guidance documents "Alternate Suture Labeling" Resulting from the January 11th 1993 meeting with HIMA.
T.CAD International believes that the subject device demonstrates a substantial equivalence to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 2000
Mr. Main M. Ghazal Trading Consultants and Distributors International, Inc. 157 WindDance Drive Chicago, Illinois 60046-6681
Re: K994002 Trade Name: Plain/Chromic Catgut Regulatory Class: II Product Code: GAL Dated: November 22, 1999 Received: November 24, 1999
Dear Mr. Ghazal:
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 that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Monday, December 11, 1989 (Vol. 54, No. 236. Pages 50737 and 50738). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- The Plain/Chromic Catgut Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
-
- This device may not be manufactured from any material other than serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacturing of the Plain/Chromic Catgut surgical suture. Any deviation of the polymer composition or processing as described in this 510(k) notification must be submitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed change(s).
4
Page 2 -- Mr. Main M. Ghazal
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.
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 809.10 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) 594-4595. 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.
Nail R.P. Ogden
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K 944002
T.CAD International 990930/MG-510(k) CATGUT
SECTION II
Statement of indication for use
Device Name: PLAIN/CHROMIC CATGUT
510(k) Number:
Indication for use:
CATGUT is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
NRo for JzD
Division Sign-Off) Division of General Restorative Devices 994002 510(k) Number _
(PLEASE DO NOT WRITE BELOW THE LINE - CONTINUE ON ANOTHER PACE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use OR
8