(10 days)
Not Found
Not Found
No
The summary describes a surgical suture, a physical medical device, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is an absorbable suture used for tissue approximation and ligation, which is a medical device but not classified as a therapeutic device in the sense of actively treating or curing a disease.
No
The provided text describes sutures, which are used for approximation and ligation of tissues. This is a therapeutic function, not a diagnostic one. There is no mention of the device being used to detect, identify, or monitor a medical condition.
No
The device description clearly states it is a monofilament synthetic absorbable 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 describes the sutures being used for "general soft tissue approximation and/or ligation" and in "pediatric cardiovascular tissue" and "peripheral vascular tissue." This is a direct surgical intervention on the body.
- Device Description: The device is described as "monofilament synthetic absorbable sutures." This is a physical medical device used for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory analysis.
Therefore, this device is a surgical suture, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Maxon** and Maxon CV** sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
Maxon** and Maxon CV** monofilament synthetic absorbable sutures (clear or green) are prepared from a copolymer of glycolic acid and trimethylene carbonate. The sutures are sterile, inert, noncollagenous and nonantigenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, pediatric cardiovascular tissue, peripheral vascular tissue
Indicated Patient Age Range
pediatric
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): 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
§ 878.4493 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
4/1/99
MAXON** SYNTHETIC, ABSORBABLE SURGICAL SUTURE
510(k)_Summary of Safety and Effectiveness V.
United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856
CONTACT PERSON: Victor M. Clavelli
DATE PREPARED: March 18, 1999
CLASSIFICATION NAME: Polyglycolic Acid Suture
Polyglycolic Acid Suture COMMON NAME:
Maxon** PROPRIETARY NAME:
Maxon** PREDICATE DEVICES:
DEVICE DESCRIPTION: Maxon** and Maxon CV** monofilament synthetic absorbable sutures (clear or green) are prepared from a copolymer of glycolic acid and trimethylene carbonate.
The sutures are sterile, inert, noncollagenous and nonantigenic.
INTENDED USE:
Maxon** and Maxon CV** sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1999
Mr. Victor M. Clavelli Manager, Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856
K990951 Re:
Trade Name: Maxon and Maxon CV Sterile Synthetic Absorbable Sutures Regulatory Class: II Product Code: GAM Dated: March 19, 1999 Received: March 22, 1999
Dear Mr. Clavelli:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). 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 devices, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- The Maxon and Maxon CV sutures are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.
-
- These devices may not be manufactured from any material other than homopolymers and copolymers of glycolide and L-lactide. 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 manufacture of the Maxon and Maxon CV surgical sutures. 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 devices.
2
Page 2 - Mr. Victor M. Clavelli
The sale, distribution and use of these devices is restricted to prescription use in accordance with 21 CFR 801.109.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
Celia 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
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MAXON** SYNTHETIC, ABSORBABLE SURGICAL SUTURE
III. Indications For Use:
| 510(k) Number (if known): | K990951 |
|---|---|
| Device Name: | Maxon** Sterile Synthetic Absorbable Suture |
Indications For Use:
Maxon and Maxon CV sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue, where growth is expected to occur, and in peripheral vascular tissue.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X |
|---|---|
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K990951 |
|---|---|
| --------------- | --------- |
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