(84 days)
Not Found
No
The summary describes a surgical suture made of synthetic materials and coated. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties and biocompatibility, not algorithmic performance.
No
The device is a surgical suture used for tissue approximation and ligation, which is a tool for surgery rather than a therapeutic device that treats or cures a condition.
No
The device is a surgical suture used for tissue approximation and ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical surgical suture made from a copolymer, not software. The performance studies also focus on physical properties and animal testing, further indicating it is a hardware device.
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 a patient's body.
- Device Description: The device is a "monofilament synthetic absorbable surgical suture." This is a physical material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Monoderm™ suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
Coated Monoderm™(Polyglactone 72) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone. Coated Monoderm™ suture is prepared by coating Monoderm™ suture with a mixture of caprolactone, glycolide and glycolic acid.
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)
Physical testing was performed on Monoderm™Coated, Synthetic, Absorbable sutures to USP 27, including Suture Diameter, Suture Needle Attachment,881> Tensile Strength. Animal testing was performed for conformance to ISO 10993 for biocompatibility and implant studies to demonstrate rates of tensile strength and mass loss.
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.
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
MAY 1 8 2004
Image /page/0/Picture/1 description: The image shows the logo for Surgical Specialties Corporation. The logo is in black and white and features the words "Surgical" and "Specialties" stacked on top of each other in a bold, sans-serif font. The word "CORPORATION" is written in a smaller font below the other two words. The image also contains the number "K040477" and the fraction "1/2" at the top.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
S
| Submitter
Address: | Surgical Specialties Corporation
100 Dennis Drive
Reading, PA 19606 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:
Contact Person: | 610 404 1000, ext. 2231
Elizabeth Lazaro
Regulatory Affairs Specialist |
| Common /
Classification Name: | Surgical Suture
Absorbable, Synthetic |
| Name of Device: | Coated Monoderm™ (Polyglactone 72) Monofilament, Synthetic
Absorbable, Dyed and/or Undyed sutures. |
| Indications for Use: | Indicated for use in general soft tissue approximation and/or ligation, but
not for use in cardiovascular or neurological tissues, microsurgery or
ophthalmic surgery. |
| Predicate Devices | Ethicon's Monocryl(Poliglecaprone 25) E caprolactone/Glycolide
510 (k) K930772 |
| | U.S. Surgical's Caprosyn (Polyglytone 6211) Glycolide, caprolactone,
trimethylene carbonate and lactide.
510 (k) K013671 |
| Device Description: | Coated Monoderm™(Polyglactone 72) suture is a monofilament
synthetic absorbable surgical suture prepared from a copolymer of
glycolide and e-caprolactone. Coated Monoderm™ suture is prepared by
coating Monoderm™ suture with a mixture of caprolactone, glycolide
and glycolic acid. |
| Performance Data: | Physical testing was performed on Monoderm™Coated, Synthetic,
Absorbable sutures to USP 27, including Suture Diameter,
Suture Needle Attachment, Tensile Strength. Animal testing
was performed for conformance to ISO 10993 for biocompatibility and
implant studies to demonstrate rates of tensile strength and mass loss. |
Monoderm™ Coated, Synthetic, Monofilament Absorbable Sutures
Surgical Specialties Corporation
1
Image /page/1/Picture/0 description: The image shows the logo for Surgical Specialties Corporation. The text "Surgical" is stacked on top of the text "Specialties". Below that is the word "CORPORATION". At the top of the image are the numbers "K040477" and "2/2".
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued
Technological
Characteristics
Surgical Specialties Corporation's Monoderm™Synthetic, absorbable suture is made from a mixture of Glycolide/e-caprolactone. The material has been well characterized through absorption studies and biocompatibility studies. The product is similar to the predicate devices, Monocryl and Caprosyn, in that they are both made from a polymer blend of synthetic absorbable materials.
Equivalency: Absorbable, Synthetic, Monofilament
Coated Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days.
Caprosyn sutures are made of synthetic absorbable sutures material, which will dissolve essentially in 56 days.
Monocryl sutures are made of synthetic absorbable suture material which will dissolve essentially between 91 and 119 days.
Monoderm™ Coated Synthetic Monofilament Absorbable Sutures Surgical Specialties Corporation
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding the upper half of the circle.
MAY 1 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K040477
Trade/Device Name: Monoderm™ Regulation Number: 21 CFR 878.4493 Regulation Name: Absorable poly(glycolide/1_lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: February 20, 2004 Received: February 24, 2004
Dear Ms. Lazaro:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved your we your we device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 conniner of the 11th 11th 2011-11-11) in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , ate , e visions of the Act include requirements for annual registration, listing of devices, good manufacturing practicc, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your de rise to such additional controls. Existing major regulations affecting your device can may be sunyeet to back at Regulations, Title 21, Parts 800 to 898. In addition, I DA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has mtatutes and regulations administered by other Federal agencies. You must or any I vatuall the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Futt 607); ideeming (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Elizabeth Lazaro
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in Jour e FDA finding of substantial equivalence of your device to a legally promation holicate 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincercly yours,
Miriam C. Provost
Fol Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Monoderm™
Indications For Use:
Monoderm™sutures are indicated for use in general soft tissue approximation and/or Monodemi ""sulures are indication for acc in yourological tissues, microsurgery or ophthalmic surgery.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_________________________________________________________________