(42 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 intended for soft tissue approximation and ligation, which is a tool used during treatment but not a device that provides therapy itself.
No
Explanation: The device, MONOCRYL suture, is described as a surgical suture for soft tissue approximation and/or ligation. Its intended use is to physically hold tissues together, not to diagnose medical conditions or provide information about a patient's health status.
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." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "monofilament synthetic absorbable surgical suture." This is a physical material used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
MONOCRYL suture, dyed is intended for use in general soft tissue approximation and/or ligation.
MONOCRYL sutures, dyed 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, dyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. MONOCRYL suture is dyed violet using D&C Violet No. 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
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. Biocompatibility and clinical was deemed unnecessary to support this labeling change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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
MAR 28 1996
MAR 2 8 1996
.
SECTION 7
K960653 (P.1002)
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. |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NEW DEVICE NAME: MONOCRYL (poliglecaprone 25) suture
dyed |
| | PREDICATE DEVICE NAME: Predicate device MONOCRYL
(poliglecaprone 25) suture, dyed |
| | 510(k) SUMMARY |
| Device Description | MONOCRYL suture, dyed is a monofilament synthetic
absorbable surgical suture prepared from a copolymer of
glycolide and epsilon-caprolactone. MONOCRYL suture is dyed
violet using D&C Violet No. 2. |
| Intended Use | MONOCRYL suture, dyed is intended for use in general soft
tissue approximation and/or ligation. |
| | MONOCRYL suture, dyed has the same intended use as
predicate device MONOCRYL suture, dyed. |
| | Continued on next page |
1
K460653 (12-23-23)
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
510(k) SUMMARY, Continued Indications Statement MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. The modified device has the same technological characteristics as Technological Characteristics the predicate device. There is no change in chemistry, material or composition. When compared to the predicate device, dyed MONOCRYL suture, MONOCRYL suture, dyed has an increased breaking strength retention (BSR) profile. Performance Data Nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and clinical was deemed unnecessary to support this labeling change. 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. Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151
Date
February 14, 1996
MONOCRYL (Poliglecaprone 25) Suture, Dyed ETHICON, Inc.