(88 days)
N85-060
No
The device description and performance studies focus on the material properties and biocompatibility of surgical sutures, with no mention of AI or ML.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which means it helps to hold tissues together or tie them off. This is a supportive function during healing and does not involve changing a biological process or structure to treat or prevent a disease, which is the definition of a therapeutic device.
No
The device description indicates that "Cutalon" Nonabsorbable Polyamide Surgical Sutures are used for soft tissue approximation and ligation, which are surgical functions, not diagnostic ones.
No
The device description clearly states it is a physical surgical suture made of nylon, which is a hardware component. There is no mention of any software functionality.
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 involves physically joining or tying off tissues within the body. This is a surgical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels. This is a therapeutic device, not a diagnostic one.
- 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, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a surgical tool used in vivo (within the living body) for treatment purposes, not an in vitro diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
"Cutalon" Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
GAR
Device Description
"Cutalon" Nonabsorbable Polyamide Surgical Sutures are composed of the long-chain aliphatic polymers extruded Nylon (Nylon 6) sutures which conform to the United States Code of Federal Regulations, 21 CFR Part, 878.5020.
"Cutalon" is a wet-packed, extruded, nylon monofilament suture. The base polymer material is Nylon 6. (As required in CFR 878.5020) The nylon suture material is foilpackaged "wet" in a solution containing isopropyl alcohol, water and other components (see below description of formulation).
The packaging fluid contains: Isopropyl Alcohol 73.65% 1.2-Propylene Glycol 15.00% Water 8.25% Glycerin 2.30% Lactic Acid 0.45% Diethanolamine 0.20% Sodium Nitrite 0.10% Ammonia 0.05%
The purpose of the "wet" packaging is to provide a nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon.
Genzyme "Cutalon" Surgical Suture are available in USP sizes 6-0 through 0 (metric sizes 0.7 through 3.5). Genzyme Cutalon Sutures meet all requirements established by the United States Pharmacopeia (USP) for nonabsorbable sutures except for diameter.
The "Cutalon" Suture is designed to maintain sterility of the product until the time of use. Each individual suture/needle assembly is wrapped around a plastic winder and the combination is placed inside an open-ended pouch. The suture assemblies in their pouches are then loaded into the packaging machine. This machine forms a polyethylene "blister" and seals a medical grade paper lid stock onto it after it is filled with packaging fluid and product. The sealed blister is placed into a purchased film/Tyvek pouch and sealed on a bar sealer. (The bar sealers were validated for outer pouch sealing for the "wet" products and a packaging machine was validated for wet packed inner blister packaging. The pouch is designated to allow sterilization with the pouch and maintain a sterile environment until the pouch is opened. The Cutalon Nylon suture is foil-packaged "wet" in a solution containing isopropyl alcohol, water and other components. The purpose once again of the "wet" packaging is to provide a Nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon.
The "wet" pouches are placed into solid bleached sulfite board boxes, with instructions for use. Polyamide suture packages are opened by peeling open the pouch. The loaded carrier is then aseptically opened in the sterile field. There is a clear film overwrap applied to the shelf box as a dust cover. Outer corrugate shipping cartons of various sizes are used to ship the suture boxes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general 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)
Biocompatibility testing was performed on Genzyme "Cutalon" Nylon Surgical Sutures which satisfied the requirements of ISO 10993-1 Biological Evaluation of Medical Devices. The biocompatibility tests conducted were:
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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
JUL 7 1998
Section 2 510(k) Summary
510(k) Summary Genzyme "Cutalon" Nonabsorbable Polyamide Surgical Suture
1. DATE PREPARED
April 7, 1998
2. SPONSOR INFORMATION
| Address: | Genzyme Surgical Products
600 Airport Road
Fall River, Massachusetts 02720 |
|------------|----------------------------------------------------------------------------------|
| Telephone: | 508-677-6679 |
| Contact: | Jim Kenney
Director, Quality Assurance/Regulatory Affairs |
3. DEVICE NAME
Proprietary Name: "Cutalon" Nonabsorbable Polyamide Surgical Suture Common/Usual Name: Nylon Nonabsorbable Polyamide Suture Classification Name: Nylon Nonabsorbable Polyamide Suture
4. DEVICE DESCRIPTION AND INTENDED USE
"Cutalon" Nonabsorbable Polyamide Surgical Sutures are composed of the long-chain aliphatic polymers extruded Nylon (Nylon 6) sutures which conform to the United States Code of Federal Regulations, 21 CFR Part, 878.5020.
"Cutalon" Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
1
5. COMPARISON TO PREDICATE DEVICE(S)
"Cutalon" Nonabsorbable Polyamide Surgical Sutures are identical in design, material, manufacturing process, function, and intended use to Nylon (Nylon 6) Nonabsorbable Surgical Sutures which are have been marketed by the Sponsor Company since 1976.
Section 3 Proposed Labeling
Draft proposed labeling for the "Cutalon" Nonabsorbable Polyamide Surgical Suture includes the actual device labeling and the package insert. Sample draft labeling for the device is provided in Appendix A.
2
Section 4 Device Description
"Cutalon" is a wet-packed, extruded, nylon monofilament suture. The base polymer material is Nylon 6. (As required in CFR 878.5020) The nylon suture material is foilpackaged "wet" in a solution containing isopropyl alcohol, water and other components (see below description of formulation).
The packaging fluid contains: Isopropyl Alcohol 73.65% 1.2-Propylene Glycol 15.00% Water 8.25% Glycerin 2.30% Lactic Acid 0.45% Diethanolamine 0.20% Sodium Nitrite 0.10% Ammonia 0.05%
The purpose of the "wet" packaging is to provide a nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon.
Genzyme "Cutalon" Surgical Suture are available in USP sizes 6-0 through 0 (metric sizes 0.7 through 3.5). Genzyme Cutalon Sutures meet all requirements established by the United States Pharmacopeia (USP) for nonabsorbable sutures except for diameter.
The "Cutalon" Suture is identical in design, materials (Nylon 6), manufacturing process and intended use to the Nylon Suture already marketed by Genzyme Surgical Products. This "Cutalon" Suture is simply a change in the packaging.
Genzyme's Nylon Suture has been on the market since December 1976. In Appendix D, please see a copy of NDA 85-060 FDA letter from December 1976 and also see a copy of the FDA's 510(k) letter dated July 26, 1994 which confirms that Genzyme has followed the instructions for "Suture Labeling Guidance" dated October 9, 1992.
3
Design, Materials, Process, Packaging
The "Cutalon" Suture is designed to maintain sterility of the product until the time of use. Each individual suture/needle assembly is wrapped around a plastic winder and the combination is placed inside an open-ended pouch. The suture assemblies in their pouches are then loaded into the packaging machine. This machine forms a polyethylene "blister" and seals a medical grade paper lid stock onto it after it is filled with packaging fluid and product. The sealed blister is placed into a purchased film/Tyvek pouch and sealed on a bar sealer. (The bar sealers were validated for outer pouch sealing for the "wet" products and a packaging machine was validated for wet packed inner blister packaging. The pouch is designated to allow sterilization with the pouch and maintain a sterile environment until the pouch is opened. The Cutalon Nylon suture is foil-packaged "wet" in a solution containing isopropyl alcohol, water and other components. The purpose once again of the "wet" packaging is to provide a Nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon.
The "wet" pouches are placed into solid bleached sulfite board boxes, with instructions for use. Polyamide suture packages are opened by peeling open the pouch. The loaded carrier is then aseptically opened in the sterile field. There is a clear film overwrap applied to the shelf box as a dust cover. Outer corrugate shipping cartons of various sizes are used to ship the suture boxes.
STERILIZATION:
| a. Sterilization Method: | Gamma Irradiation (Cobalt 60) |
|---|---|
| b. Validation Method: | AAMI/ANSI/ISO 11137 Sterilization of health care |
| products-Requirements for validation and routine | |
| control-Radiation sterilization. | |
| c. Sterility Assurance | |
| Level | $10^{-6}$ |
4
Substantial Equivalence and Comparison Information Section 5
The "Cutalon" Nonabsorbable Polyamide Surgical Suture is identical in design, materials, manufacturing process, function and intended use to the predicate device, Genzyme's Nylon Suture.
Genzyme's Nylon Suture has been on the market since December 1976. In Appendix C, please see a copy of NDA 85-060 FDA letter from December 1976 and also see a copy of the FDA's 510(k) #K930738 letter dated July 26, 1994 which confirms that Genzyme has followed the instructions for "Suture Labeling Guidance" dated October 9, 1992.
| Table 1
| "Cutalon" Nylon Sutures Compared to Predicate Suture Product | ||
|---|---|---|
| "Cutalon" Suture | Nylon Suture | |
| Intended Use | General soft tissue approximation and/or ligation | General soft tissue approximation and/or ligation |
| Suture Material | Nylon 6 or 6.6 | Nylon 6 or 6.6 |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation or ETO |
| How provided | Sterile for Single Use Only | Sterile for Single Use Only |
| USP Sizes | 6-0 thru 0 | 10-0 thru 5 |
| Suture Tensile Strength | Meets USP Requirement | Meets USP Requirement |
| Packaging | Wet Packaged (sterile) | Dry Packaged (sterile) |
5
Section 6 Biocompatibility Information
Biocompatibility testing was performed on Genzyme "Cutalon" Nylon Surgical Sutures which satisfied the requirements of ISO 10993-1 Biological Evaluation of Medical Devices. The biocompatibility tests conducted were: