(18 days)
Not Found
Not Found
No
The document describes a traditional surgical suture and does not mention any AI or ML components or functionalities.
No
The device is a surgical suture used for approximation and ligation of tissues, not for treating a disease or condition.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which is a therapeutic function, not a diagnostic one. It does not identify or investigate medical conditions.
No
The device description clearly states it is a "flexible suture thread" manufactured from animal tissue, which is a physical, non-software component. The performance studies also focus on physical properties and biological interactions, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "general soft tissue approximation and/or ligation," which is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "flexible suture thread," which is a physical material used to close wounds or tie off blood vessels during surgery. This is not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information.
In summary, the device is a surgical suture, which is a medical device used in vivo (within the body) for surgical procedures, not an in vitro diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
AESCULAP® Absorbable Surgical Gut Sutures and Softcar® Absorbable Surgical Gut Sutures are indicated for use in all types of gencral soft tissue approximation and/or ligation, including ophthalmic procedures, but not for use in cardiovascular or neural tissue. Absorbable Surgical Gut Suture is indicated for use in general soft rissue approximation and/or ligation , including use in ophthalmic nssac upproximation and in cardiovascular or neural tissues.
Product codes (comma separated list FDA assigned to the subject device)
GAL
Device Description
The subject device is an absorbable, flexible suture thread, available in both plain and chromicized forms, which is supplied sterile. It is manufactured from the serosal connective tissue layer of bovine intestine or the submucosal layer of ovine intestine. It is indicated for general soft tissue approximation and/or ligation, including ophthalmic tissues, but not including cardiovascular or neural tissues. It is undyed, and is available with and without needles attached. In the Softcar® form, both plain and chromic sutures are treated with glycerol.
The subject Absorbable Surgical Gut Suture is composed of processed strands of bovine serosa or ovine submucosa, materials equivalent, if not identical, to those comprising the predicate sutures. The subject device is offered both plain, and chromicized to prolona its in vivo strength retention. In addition, the Softcar® plain and chromic forms of the subject device have been treated with a glycerol solution to enhance handling properties, in the same fashion as the predicate Davis & Geck SOFTGUT® suture.
The subject device has the same design as do the Ethicon and Davis & Geck predicate devices, being a sterile, flexible thread available in sizes 6-0 (1 Metric) through 4 (8 Metric), being offered with or without one of a selection of standard needles attached, and conforming in all respects to the requirements of the Official Monograph for Absorbable Surgical Suture in U.S.P. XXIII, including Sutures -- Diameter, Sutures -- Needle Attachment, and Tensile Strength. .
As is also the case with the predicate devices, the sutures are offered either plain, or treated with a chromic salt and cross-linked to increase resistance to degradation in vivo, thereby prolonging tensile strength retention. Both plain and chromic sutures are offered in traditional packaging containing an alcohol solution to prevent spruing caused by drying during storage.
Alternatively, as is the case with the predicate Davis & Geck SOFTGUT® sutures, Softcat® plain and chromic sutures are treated with a glycerol solution before packaging to prevent spruing and to preserve handling properties.
Physical properties of the subject device are substantially equivalent to those of the Ethicon and Davis & Geck predicate devices, including fiber diameter, knot pull tensile strength, straight pull tensile strength, flexibility, knot security, and needle attachment strength, among others.
The subject device is manufactured in a manner typical of the industry, and equivalent to that used to produce predicate devices, wherein bovine serosa or ovine submucosa are harvested from healthy animals, cut into long strips which are cleaned mechanically and chemically to remove non-collagenous materials, twisted together to form monfilament-like strands, dried, polished to uniform diameter, cut to length, and attached to needles to make finished sutures. A series of chromicizing and cross-linking baths are added to the process to make chromic sutures, and both plain and chromic sutures are either packaged in an alcohol solution to prevent fiber drying during storage, or treated with a glycerol solution to condition the fibers before packaging. Given that the subject device is made from the same materials, and in essentially the same fashion, as the Ethicon and Davis & Geck predicate devices, the subject device can be expected to have the same or equivalent chemical characteristics, physical properties, biocompatibility, and in vivo performance properties as do the predicate devices.
The subject device is packaged and sterilized in the same or equivalent manner, and has the same or equivalent labeling claims as do the predicate devices, including indications, contraindications, warnings, cautions and precautions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, ophthalmic tissues
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 conducted on the subject device to demonstrate its substantial cquivalence to predicate devices included testing of physical properties to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, implant studies in animals to demonstrate rates of tensile strength and mass loss, and shelf life and sterilization validation studies.
Clinical Tests: (Not applicable)
Results: The results of all testing demonstrated the substantial equivalence, if not superiority, of the subject device to one or more predicate devices.
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.
Not Found
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).
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).
§ 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
4/30/95
AESCULAP®
VII. 510(k) Summary
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A . Submitted By
AESCULAP® 1000 Gateway Boulevard South San Francisco, California 94080-7030 Telephone: (415) 876-7000 Contact: Victoria Mackinnon, Director of Regulatory Affairs & Quality Assurance Date Prepared: April 6, 1999
B . Device Name
| Trade or Proprietary Name: | Absorbable Surgical Gut Suture, plain and
chromic; Softcat® Absorbable Surgical Gut
Suture, plain and chromic |
|----------------------------|---------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Absorbable Surgical Gut Suture, plain and
chromic |
| Classification Name: | Absorbable Surgical Gut Suture |
C. Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
- Plain and Chromic Absorbable Surgical Suture (Davis & Geck)) .
- Plain and Chromic Absorbable Surgical Suture (Ethicon, Inc.) .
- . SOFTGUT® Plain and Chromic Absorbable Surgical Suture (Davis & Geck)
- SURGIGUT® Plain and Chromic Absorbable Surgical Gut Suture (U.S. . Surgical Corporation)
1
D. Device Description
The subject device is an absorbable, flexible suture thread, available in both plain and chromicized forms, which is supplied sterile. It is manufactured from the serosal connective tissue layer of bovine intestine or the submucosal layer of ovine intestine. It is indicated for general soft tissue approximation and/or ligation, including ophthalmic tissues, but not including cardiovascular or neural tissues. It is undyed, and is available with and without needles attached. In the Softcar® form, both plain and chromic sutures are treated with glycerol.
E. Intended Use
AESCULAP® Absorbable Surgical Gut Sutures and Softcar® Absorbable Surgical Gut Sutures are indicated for use in all types of gencral soft tissue approximation and/or ligation, including ophthalmic procedures, but not for use in cardiovascular or neural tissue.
F. Comparison to Predicate Devices
The subject Absorbable Surgical Gut Suture is composed of processed strands of bovine serosa or ovine submucosa, materials equivalent, if not identical, to those comprising the predicate sutures. The subject device is offered both plain, and chromicized to prolona its in vivo strength retention. In addition, the Softcar® plain and chromic forms of the subject device have been treated with a glycerol solution to enhance handling properties, in the same fashion as the predicate Davis & Geck SOFTGUT® suture.
The subject device has the same design as do the Ethicon and Davis & Geck predicate devices, being a sterile, flexible thread available in sizes 6-0 (1 Metric) through 4 (8 Metric), being offered with or without one of a selection of standard needles attached, and conforming in all respects to the requirements of the Official Monograph for Absorbable Surgical Suture in U.S.P. XXIII, including Sutures -- Diameter, Sutures -- Needle Attachment, and Tensile Strength. .
2
As is also the case with the predicate devices, the sutures are offered either plain, or treated with a chromic salt and cross-linked to increase resistance to degradation in vivo, thereby prolonging tensile strength retention. Both plain and chromic sutures are offered in traditional packaging containing an alcohol solution to prevent spruing caused by drying during storage.
Alternatively, as is the case with the predicate Davis & Geck SOFTGUT® sutures, Softcat® plain and chromic sutures are treated with a glycerol solution before packaging to prevent spruing and to preserve handling properties.
Physical properties of the subject device are substantially equivalent to those of the Ethicon and Davis & Geck predicate devices, including fiber diameter, knot pull tensile strength, straight pull tensile strength, flexibility, knot security, and needle attachment strength, among others.
The subject device is manufactured in a manner typical of the industry, and equivalent to that used to produce predicate devices, wherein bovine serosa or ovine submucosa are harvested from healthy animals, cut into long strips which are cleaned mechanically and chemically to remove non-collagenous materials, twisted together to form monfilament-like strands, dried, polished to uniform diameter, cut to length, and attached to needles to make finished sutures. A series of chromicizing and cross-linking baths are added to the process to make chromic sutures, and both plain and chromic sutures are either packaged in an alcohol solution to prevent fiber drying during storage, or treated with a glycerol solution to condition the fibers before packaging. Given that the subject device is made from the same materials, and in essentially the same fashion, as the Ethicon and Davis & Geck predicate devices, the subject device can be expected to have the same or equivalent chemical characteristics, physical properties, biocompatibility, and in vivo performance properties as do the predicate devices.
The subject device is packaged and sterilized in the same or equivalent manner, and has the same or equivalent labeling claims as do the predicate devices, including indications, contraindications, warnings, cautions and precautions.
3
G . Summary of Non-Clinical Tests
Non-clinical testing conducted on the subject device to demonstrate its substantial cquivalence to predicate devices included testing of physical properties to prove conformance to the requirements of U.S.P., in vitro and in vivo biosafety studies, implant studies in animals to demonstrate rates of tensile strength and mass loss, and shelf life and sterilization validation studies.
H . Summary of Clinical Tests
(Not applicable)
I. Conclusions of Non-Clinical and Clinical Tests
The results of all testing demonstrated the substantial equivalence, if not superiority, of the subject device to one or more predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three birds in flight, depicted with curved lines to suggest movement and freedom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1999
AESCULAP c/o Mr. Steve Reitzler, RAC 13221 Maricotte Place San Diego, California 92130
Re: K991223
Trade Name: Absorbable Surgical Gut Suture, and SOFTCAT® Absorbable Surgical Suture
Regulatory Class: II Product Code: GAL Dated: April 6, 1999 Received: April 12, 1999
Dear Mr. Reitzler:
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 Absorbable Surgical Gut Suture and SOFTCAT® Absorbable Surgical Suture is 1. 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 Absorbable Surgical Gut Suture and SOFTCAT® Absorbable 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).
5
Page 2 - Mr. Steve Reitzler
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 The general controls provisions of the Act include requirements of regioned in the problem in the adulteration.
Existing major regulations affecting your device can be found in the Code of Federal
. Existing major regulations arrecting your avversion and Drug Administration
Regulations, Title 21, Parts 800 to 895. In addition, the Federal Regis Regulations, Title 21, Parts 800 to 893, 111 addition, more ance in the Federal Register.
(FDA) may publish further announcements concerning your device in the Federal any (FDA) may publish further announcements contribution submission does not affect any Please note: this response to your premarker nontrol 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)
. In the may and on the collected as a few interceiple on wour dcyice to This letter will allow you to begin malicoling of substantial equivalence of your device to a
premarket notification. The FDA finding of substition for vour device and thus, premarket notification. The FDA finding of substantial equiration of 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)
Carties of the same and since in the income includes contract the Office of If you desire specific advice for your ucvace on on our accessions of the Office of
and additionally 809.10 for in vitro 41 love of excellence the promotion and and additionally 809.10 for in Milly diagnolic de rocs), product on the promotion and Compliance at (301) 594-4392. Aduntonally, NY (405.70mpliance at (301) 594-4595.
advertising of your device, please contact the Office by Compliance to premarket advertising of your device, piease contact the oranding by reference to premarket.
Also, please note the regulation entitled, "Misbranding on your responsibility Also, please note the regulation entitled, "Misoration on your responsibilities under the
notification" (21 CFR 807.97). Other general information on your responsibilities u notification" (21 CFR 807.97). Outler gench internations veers Assistance at its toll-free
Act may be obtained from the Division of Small Manufacturers Act may be obtained none 1701) 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
Enclosure
6
Draft Labeling v.
A . Indications for Use
510(k) Number (if known): K991223
Device Name: AESCULAP® Absorbable Surgical Gut Suture
Indications for Use:
Absorbable Surgical Gut Suture is indicated for use in general soft rissue approximation and/or ligation , including use in ophthalmic nssac upproximation and in cardiovascular or neural tissues.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991223 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| ------------------------------------------ | ---- | ----------------------------- |