(62 days)
Not Found
No
The summary describes a surgical suture and its physical and biological properties, with no mention of AI or ML.
No
This device is a surgical suture used for tissue approximation and ligation, which is a tool used during medical procedures, not a therapeutic device designed to treat a condition itself.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device is a surgical suture, which is a physical medical device, not software. The description details its material composition and physical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that Monoderm™ sutures are "monofilament synthetic absorbable surgical sutures" used for "general soft tissue approximation and/or ligation." This means they are implanted within the body during surgery to hold tissues together.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
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
GAM
Device Description
MonodermTM suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone.
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 MonodermTM 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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NOV - 7 2005
Kosz437
of 2
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
| 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: | Modified MonodermTM 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 |
| | Surgical Specialties Corporation's (Polyglytone 72) Glycolide, and e-
caprolactone.
510 (k) K040477 |
| Device Description: | MonodermTM suture is a monofilament synthetic absorbable surgical
suture prepared from a copolymer of glycolide and e-caprolactone. |
| Performance Data: | Physical testing was performed on MonodermTM 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. |
Modified Monoderm™ Synthetic, Monofilame nt Absorbable Sutures Surgical Specialties Corporation
1
052437
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, Monoderm (Polyglactone 72) and Monocryl in that they are both made from a polymer blend of synthetic absorbable materials.
Equivalency:
Absorbable, Synthetic, Monofilament
Surgical Specialties Corporation's Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days.
Ethicon`s
Monocryl sutures are made of synthetic absorbable suture material which will dissolve essentially between 91 and 119 days.
Modified Monoderm™ Synthetic Monofilament Absorbable Sutures Surgical Specialties Corporation
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three parallel lines representing health, services, and people. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2005
Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K052437
Trade/Device Name: Monoderm™ Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: September 2, 2005 Received: September 6, 2005
Dear Ms. Lazaro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the 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 to devices that have been reclassified 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 forth in the quality systems (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- Elizabeth Lazaro
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your maneting of your device to a legally premarket notification. THC PDF mising of cation 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 If you desire specific advice for your acon 1000) 276-0115. Also, please note the regulation entitled, Colliact the Oritec of Compliance an (21 t retification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K052437 510(k) Number (if known):
Device Name: Monoderm™ Synthetic Absorbable Surgical Suture
Indications for Use:
Monoderm™sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saubaie Mullins for Nixon
Division of General, Restorative, and Neurological Devices
Page 1 of 1
(k) Number K052437
510(k) Number