(75 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a surgical suture, with no mention of AI or ML.
No
The device is a surgical suture used for approximation and ligation of tissues, which is a tool used during treatment but not itself a therapeutic device that delivers therapy or treats a condition.
No
Explanation: The device is a surgical suture, which is used for approximation and/or ligation of tissue, indicating a therapeutic or reconstructive function rather than a diagnostic one.
No
The device description clearly states it is a "sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid." This describes a physical, tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general soft tissue approximation and/or ligation, including use in ophthalmic procedures". This describes a device used within the body during a surgical procedure.
- Device Description: The description details a "sterile, absorbable, braided multifilament suture". This is a physical material used for stitching tissue.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
The information provided describes a surgical implant/device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Bondek Synthetic Absorbable 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.
Product codes
GAM
Device Description
Bondek Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K905482, K930378, K946271, K915835, K965162
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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 Bondek® Synthetic Absorbable surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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
Image /page/0/Picture/1 description: The image shows the text "K99 1191" in a bold, handwritten font. The text is black against a white background. The numbers are slightly slanted to the right.
EXHIBIT I
510(k) Summary of Substantial Equivalence - -
BONDEK ® Synthetic Absorbable Surgical Suture
In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule "…. 510(k) Summaries and 510(k) Statements…" and can be used to provide equivalence summary to anyone requesting it from the Agency.
| Manufacturer | Genzyme Surgical Products
600 Airport Road
Fall River, MA 02720-4740 |
|---------------------------|---------------------------------------------------------------------------------|
| Contact Person | Mary E. Gray |
| | Phone: (508) 677-6512 |
| | Fax: (508) 677-6663 |
| | e-mail: mgray@genzyme.com |
| Device Information | |
| Trade Name: | Bondek ® Polyglycolic Acid Synthetic
Absorbable Surgical Suture |
| Common Name: | Polyglycolic Acid Synthetic Absorbable
Surgical Suture |
| Classification Name: | Absorbable poly(glycolide/L-lactide)
surgical suture (per 21 CFR § 878.4493) |
Indications for Use
Bondek Synthetic Absorbable 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.
Device Description
Bondek Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.
1
K99
EXHIBIT I
510(k) Summary of Substantial Equivalence Cont. BONDEK ® Synthetic Absorbable Surgical Suture
Substantial Equivalence
The Bondek Synthetic Absorbable Surgical Suture is similar in intended use, materials, design, and performance characteristics to the Bondek Synthetic Absorbable Surgical Suture (#K905482 and #K930378), Ethicon, Inc. Vicryl® suture (#K946271, #K915835), and Lukens Medical Corp. Lukens® PGA suture (#K965162).
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ISO 10993-1 Biological Evaluation of Medical Deices, U.S.P. Section 1475 - Absorbable Surgical Sutures, and the FDA Guidance Document "Alternate Suture Labeling Resulting from January 11, 1993 Meeting with HIMA"
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 1999
Ms. Mary Gray Regulatory Affairs Specialist Genzyme Surgical Products Corp. 600 Airport Road Fall River, Massachusetts 02720
Re: K991191
Trade Name: Bondek® Synthetic Absorbable Surgical Suture Regulatory Class: II Product Code: GAM Dated: April 7, 1999 Received: April 8, 1999
Dear Ms. Gray:
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 Wednesday, September 18, 1991 (Vol. 56, No. 18, Pages 47150 and 47151). 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 Bondek® Synthetic Absorbable Surgical Suture is indicated for use in general 1. 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 homopolymers 2. and copolymers made from glycolide and/or L-lactide. 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). 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 Bondek® Synthetic Absorbable surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
3
Page 2 - Ms. Mary Gray
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. 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, 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) 594-4639. 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,
L. Celie M. Witten, Ph.D., M.D.
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
4
KSgn91
510(k) Number (if known) Device Name
Bondek® Synthetic Absorbable Surgical Suture
. .
Indications for Use
Bondek® Synthetic Absorbable 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.
:
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sigh-Off) Division of General Restorative Devices 12991191 510(k) Number __
Prescription Use (Per 21 CFR § 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)