(84 days)
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.
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.
The provided text describes a 510(k) summary for a surgical suture device (Monoderm™), which focuses on establishing substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the kind of details requested.
Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, ground truth for training set) are not applicable or not provided in this type of regulatory submission.
However, I can extract information related to performance data and equivalency claims as much as possible.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
This information is not presented in a table format with explicit acceptance criteria values. Instead, the document states general conformance to standards and describes performance relative to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to USP 27 standards for surgical sutures. | "Physical testing was performed on Monoderm™Coated, Synthetic, Absorbable sutures to USP 27, including <861>Suture Diameter, <871>Suture Needle Attachment,<881> Tensile Strength." (Specificity of "conformance" implies meeting the USP requirements, but no specific values are given.) |
| Biocompatibility (ISO 10993) | "Animal testing was performed for conformance to ISO 10993 for biocompatibility..." (Specificity of "conformance" implies meeting the ISO requirements, but no specific results are given.) |
| Rates of tensile strength and mass loss (in vivo / implant studies) | "...and implant studies to demonstrate rates of tensile strength and mass loss." (No specific rates or numerical performance values are provided, only that studies were done to demonstrate them.) |
| Dissolution / Absorption Time | "Coated Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days."(Comparison to predicates: Caprosyn: 56 days; Monocryl: 91-119 days) |
| Material composition and 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." (This is more of a characteristic description than a performance metric with an acceptance criterion.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document mentions "Physical testing" and "Animal testing" but does not give the number of samples or animals used.
- Data Provenance: Not specified. The studies were performed by Surgical Specialties Corporation. The country of origin of the data is not mentioned. Whether studies were retrospective or prospective is also not stated, but typically, these types of tests for product clearance are prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not the type of device or study that typically involves expert ground truth for a test set in the way an AI diagnostic device would. Performance is assessed against physical and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this physical and biological product testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a surgical suture, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For physical testing (diameter, needle attachment, tensile strength), the "ground truth" would be established by standardized measurement techniques defined by USP 27.
- For biocompatibility and implant studies, the "ground truth" would be established by histopathological examination and assessment of biological responses according to ISO 10993 guidelines, and measurement of physical properties (tensile strength, mass loss) over time.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML product developed with training sets.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML product developed with training sets.
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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
| SubmitterAddress: | Surgical Specialties Corporation100 Dennis DriveReading, PA 19606 |
|---|---|
| Telephone:Contact Person: | 610 404 1000, ext. 2231Elizabeth LazaroRegulatory Affairs Specialist |
| Common /Classification Name: | Surgical SutureAbsorbable, Synthetic |
| Name of Device: | Coated Monoderm™ (Polyglactone 72) Monofilament, SyntheticAbsorbable, Dyed and/or Undyed sutures. |
| Indications for Use: | Indicated for use in general soft tissue approximation and/or ligation, butnot for use in cardiovascular or neurological tissues, microsurgery orophthalmic surgery. |
| Predicate Devices | Ethicon's Monocryl(Poliglecaprone 25) E caprolactone/Glycolide510 (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 monofilamentsynthetic absorbable surgical suture prepared from a copolymer ofglycolide and e-caprolactone. Coated Monoderm™ suture is prepared bycoating Monoderm™ suture with a mixture of caprolactone, glycolideand glycolic acid. |
| Performance Data: | Physical testing was performed on Monoderm™Coated, Synthetic,Absorbable sutures to USP 27, including <861>Suture Diameter,<871>Suture Needle Attachment,<881> Tensile Strength. Animal testingwas performed for conformance to ISO 10993 for biocompatibility andimplant studies to demonstrate rates of tensile strength and mass loss. |
Monoderm™ Coated, Synthetic, Monofilament Absorbable Sutures
Surgical Specialties Corporation
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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
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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.
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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
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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_________________________________________________________________
§ 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.