(68 days)
Not Found
Not Found
No
The summary describes a surgical suture and does not mention any AI or ML components or functionalities.
No.
The device is a surgical suture used for tissue approximation and ligation, which is a structural or supportive function, not a therapeutic one aimed at treating a disease or condition.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a monofilament synthetic absorbable surgical suture, which is a physical medical device, 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" during surgery. This is a direct surgical intervention on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is a "monofilament synthetic absorbable surgical suture." This is a physical material used to hold tissue together, not a reagent, instrument, or system used for in vitro examination.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, this device falls under the category of a surgical implant or device used for direct treatment, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation.
Modified MONOCRYL sutures, undyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Product codes
Not Found
Device Description
MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone.
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)
Nonclinical laboratory testing was performed to determine breaking strength retention profile after implantation. It was determined that the BSR profile for Modified MONOCRYL suture, undyed is identical to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MONOCRYL (poliglecaprone 25) suture, dyed
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 8 1996
SECTION 7
K 9684072
SUMMARY OF SAFETY AND EFFECTIVENESS
| 510(k) Summary of Safety and Effectiveness | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
|---|---|
| MODIFIED DEVICE NAME: MONOCRYL (poliglecaprone 25) suture, undyed | |
| PREDICATE DEVICE NAME: MONOCRYL (poliglecaprone 25) suture, dyed | |
| 510(k) SUMMARY | |
| Device Description | MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. |
| Intended Use | MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation. |
| MONOCRYL suture, undyed has the same intended use as predicate device MONOCRYL suture, dyed. | |
| Continued on next page |
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued
:
| Indications Statement | Modified MONOCRYL sutures, undyed are indicated for soft
tissue approximation and/or ligation, but not for use in
cardiovascular or neurological tissues, microsurgery or
ophthalmic surgery. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The modified device has the same technological
characteristics as the predicate device. There is no change in
material or chemical compound. Modified MONOCRYL suture,
undyed has an increased breaking strength retention (BSR)
profile identical to the predicate device. |
| Performance Data | Nonclinical laboratory testing was performed to determine
breaking strength retention profile after implantation. It was
determined that the BSR profile for Modified MONOCRYL
suture, undyed is identical to the predicate device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug, and Cosmetic Act. |
| Contact | John D. Paulson, Ph.D.
Vice President, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | October 9, 1996 |