(526 days)
DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.
DemeQUICK Absorbable suture is an absorbable sterile surgical suture composed of copolymers made from 90% alvcolide and 10% L-lactide. DemeQUICK Absorbable suture is coated with a copolymer made from 30% glycolide 70% L-lactide and calcium stearate, it is available un-dved from sizes: USP 6-0 to USP 2. The DemeQUICK Absorbable suture complies with the requirements established by the United States Pharmacopoeia (USP) for absorbable suture, with tensile strength meeting the collagen table.
Here's an analysis of the provided text regarding the DemeQUICK (Rapid Absorbable) Surgical Suture, structured to address your requested points about acceptance criteria and the study proving compliance:
The document provided is a 510(k) summary, which is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device. For this type of submission, extensive clinical trials with human subjects as we typically associate with "AI studies" are generally not required. Instead, the focus is on non-clinical testing to demonstrate performance equivalence to established standards and predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DemeQUICK Absorbable Suture are based on conformance to the requirements of the United States Pharmacopeia (USP) for absorbable sutures and demonstrating substantial equivalence to the specified predicate devices (Riverpoint's Vilet Quick® and Ethicon's Vicryl Rapide®). The reported device performance is consistently stated as "Same" relative to the predicate devices, implying that DemeQUICK meets or exceeds these criteria.
| Acceptance Criteria (Based on USP and Predicate Equivalence) | Reported Device Performance (DemeQUICK Absorbable Suture) |
|---|---|
| Suture meets or exceeds the performance requirements for "Absorbable Surgical Suture" as defined in the Official Monograph of the United States Pharmacopeia. | Same (as predicate devices) |
| Suture Materials meet the performance requirements for Diameter as defined in the United States and European Pharmacopeias. | Same (as predicate devices) |
| Suture meets or exceeds the performance requirements defined in the United States Pharmacopeia for "Tensile Strength" <881> (collagen table). | Same (as predicate devices) |
| Suture Material meets or exceeds the performance requirements defined in the United States Pharmacopeia and the current edition USP for "Needle Attachment" <871>. | Same (as predicate devices) |
| Suture meets or exceeds the performance requirements defined in the United States Pharmacopeia for "Suture Length Requirement" (95% of stated label length). | Same (as predicate devices) |
| Suture is packaged in a same or equivalent manner with sterile single or double package having labeling conforming to 21 CFR and current edition of USP. | Same (as predicate devices) |
| Suture Material is a composition of absorbable flexible, braided thread prepared from 90% glycolide and 10% L-lactide. | Same (as predicate devices) |
| Suture material is offered un-dyed. | Same (as predicate devices) |
| Suture material is supplied coated. | Same (as predicate devices) |
| Suture is sterilized by Gamma Irradiation. | Same (as predicate devices) |
| Suture Material is designed as a sterile, flexible, braided thread offered in a variety of lengths and a range of diameters with or without various needles attached. | Same (as predicate devices) |
| Progressive loss of tensile strength and eventual absorption occurs by means of hydrolysis, with absorption essentially complete in approximately 30 to 40 days. | Same (as predicate devices) |
| Indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. Not intended for ligation, cardiovascular, ophthalmic or neurological procedures. | Same (as predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each non-clinical test conducted (e.g., number of sutures tested for tensile strength or diameter). It mentions "Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture..." This implies that standard methods outlined in the USP were followed, which would have specified sample sizes for such tests.
- Test Set Sample Size: Not explicitly stated for individual tests, but implied to follow USP guidelines.
- Data Provenance: The testing was conducted in a non-clinical setting to conform to USP requirements and establish biocompatibility (ISO 10993-1). The nature of these tests (e.g., physical property measurements, in-vitro/in-vivo resorption studies) suggests laboratory-based data, not necessarily tied to a specific country of origin in the way clinical data would be. The data is retrospective in the sense that it's generated from manufactured product for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This request is not directly applicable to this type of device submission. For surgical sutures, "ground truth" is not established by expert clinical consensus in the way seen with diagnostic AI studies. Instead, the "ground truth" for acceptance is defined by:
- USP Monograph Requirements: These are objective, measurable physical and chemical properties (e.g., minimum tensile strength, diameter tolerances) established by a pharmacopeial authority.
- Biocompatibility Standards: ISO 10993-1 provides a framework for evaluating biological responses to medical devices via standardized tests, not expert opinion.
- Performance of Legally Marketed Predicate Devices: The DemeQUICK suture is compared against two existing, approved sutures. Their performance serves as a benchmark for equivalence.
Therefore, no clinical experts are involved in establishing the "ground truth" for the non-clinical tests described.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for this type of device is based on objective, standardized physical, chemical, and biological tests, not on subjective assessment or consensus among clinical experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-powered) where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. For a surgical suture, the effectiveness is proven through physical performance, biocompatibility, and absorption characteristics, not through human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The testing conducted for the DemeQUICK suture is analogous to "standalone" performance. The device's physical and chemical properties, as well as its biocompatibility and absorption profile, are evaluated independently against specified standards and predicate devices, without involving a human practitioner's real-time interaction or interpretation in a clinical setting as part of the primary equivalence demonstration.
7. The Type of Ground Truth Used
The ground truth used for DemeQUICK's assessment is primarily:
- Standardized Specifications: The official Monograph of the United States Pharmacopeia (USP) requirements for absorbable surgical sutures, including specific tests for diameter, tensile strength, needle attachment, and length.
- Biocompatibility Standards: ISO 10993-1 guidelines for biological evaluation of medical devices.
- Performance Data from Predicate Devices: The established performance characteristics of Riverpoint's Vilet Quick® and Ethicon's Vicryl Rapide® sutures act as a comparative "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This concept is not applicable here. A "training set" is used for machine learning or AI models. This submission is for a physical medical device (suture) and does not involve AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for "DemeTECH". The logo consists of a stylized triangle inside of a circle on the left, followed by the company name in a bold, italicized font. The "CH" in "DemeTECH" is slightly smaller and raised, with a registered trademark symbol next to it.
1 of 3
MAY 30 2014
510K Summary
This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Demetech Sutures to those of the legally marked devices listed. ,
| A. | Applicant: | Demetech Corporation,14175 NW 60th Ave.Miami Lakes FL. 33014 |
|---|---|---|
| B. | Contact Person: | Luis ArguelloEmail: luis@demetech.usPhone # 305-824-1048 Ext 113 |
| Alternate Contact | Anthony J Dimercurio, tony@demetech.us | |
| C. | Date Prepared: | May 29, 2014 |
| D. | Trade Name: | DemeQUICK (Rapid Absorbable) SurgicalSuture |
| Common Name: | PGLA Rapid Absorbable SurgicalSuture | |
| Classification Name: | Absorbable poly (glycolide/l-lactide) SurgicalSuture braided or monofilament |
- Predicate Devices: DemeQUICK (Rapid Absorbable) Surgical Suture is substantially E. equivalent to these following two predicate devices:
- Device Description: F.
DemeQUICK Absorbable suture is an absorbable sterile surgical suture composed of copolymers made from 90% alvcolide and 10% L-lactide. DemeQUICK Absorbable suture is coated with a copolymer made from 30% glycolide 70% L-lactide and calcium stearate, it is available un-dved from sizes: USP 6-0 to USP 2. The DemeQUICK Absorbable suture complies with the requirements established by the United States Pharmacopoeia (USP) for absorbable suture, with tensile strength meeting the collagen table.
- ું. Intended Use:
DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.
{1}------------------------------------------------
Non-Clinical Tests Performed: H.
Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, blocompatibility testing in accordance to ISO 10993-1 and in-vitro and in-vivo resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterlity to methods outlined in USP 35,
| COMPARISON TABLE DEMEQUICK ABSORBABLE TO PREDICATE DEVICES | |||
|---|---|---|---|
| Comparison Items | DemeQUICKAbsorbableSuture | RiverpointMedical ViletQuick®Suture | EthiconVicryl Rapide®Suture |
| Suture meets or exceeds the performancerequirements for "Absorbable SurgicalSuture" as defined in the Official Monographof the United States Pharmacopeia. | Same | Same | Same |
| Suture Materials meet the performancerequirements for Diameter as defined in theUnited States and European Pharmacopeias | Same | Same | Same |
| Suture meets or exceeds the performancerequirements defined in the United StatesPharmacopeia for "Tensile Strength" < 881 >collagen | Same | Same | Same |
| Suture Material meets or exceeds theperformance requirements defined in theUnited States Pharmacopeia and the currentedition USP for "Needle Attachment" < 871 > | Same | Same | Same |
| Suture meets or exceeds the performancerequirements defined in the United StatesPharmacopeia for "Suture LengthRequirement" (95% of stated label length) | Same | Same | Same |
| Suture is packaged in a same or equivalentmanner with sterile single or double packagehaving labeling conforming to 21 CFR andcurrent edition of USP. | Same | Same | Same |
| Suture Material is a composition ofabsorbable flexible, braided thread preparedfrom 90% glycolide and 10% L-lactide | Same | Same | Same |
{2}------------------------------------------------
| 3 | of | 3 |
|---|---|---|
| --- | ---- | --- |
| Suture material is offered un-dyed | Same | Same | Same |
|---|---|---|---|
| Suture material is supplied coated | Same | Same | Same |
| Suture is sterilized by Gamma Irradiation | Same | Same | Same |
| Suture Material is designed being a sterile,flexible, braided thread offered in a variety oflengths and a range of diameters with orwithout various needles attached. | Same | Same | Same |
| Progressive loss of tensile strength andeventual absorption of DemeQUICK (RapidAbsorbable) Surgical Suture occurs bymeans of hydrolysis. Absorption begins as aloss of tensile strength followed by a loss ofmass. Absorption is essentially complete inapproximately 30 to 40 days. | Same | Same | Same |
| DemeQUICK (Rapid Absorbable) SyntheticSurgical Suture is indicated for use ingeneral soft tissue approximation (i.e.,mucosa and skin) where only short termwound support (7-10 days) is required.DemeQUICK (Rapid Absorbable) SyntheticSurgical Suture is not intended for use inligation, cardiovascular, ophthalmic orneurological procedures. | Same | Same | Same |
DemeQUICK (Rapid Absorbable) Surgical Suture is composed of the same material as are the predicated devices using the same design' being a sterile, flexible, multifilament threads meeting the requirements of the United States Pharmacopeia. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is manufactured in the same manner as the predicate devices, being produced from 90% glycolide and 10% L-lactide manufactured in operations considered standard in the fiber industry to form the finished suture fiber in bulk. The manufacturer supplies the identical bulk fibers to Demetech as it sells to other suture manufacturers including those with approved 510K submissions.
A summary of recent USP performance testing results are presented below on gamma sterilized finish sutures, together with the gamma sterilized Biocompatibility documentation already submitted to FDA, demonstrates the substantial equivalence of DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture to that of the predicated devices.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Flampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
May 30, 2014
DemeTECH Corporation % Mr. John O Brien AJW Technology Consultants Incorporated 445 Apollo Beach Boulevard Apollo Beach, Florida 33572
Re: K123940
Trade/Device Name: DemeQUICK (Rapid Absorbable) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/l-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: May 7, 2014 Received: May 28, 2014
Dear Mr. O Brien:
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 10 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{4}------------------------------------------------
Page 2 - Mr. John O'Brien
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for DemeTECH. The logo consists of a stylized mountain peak to the left of the company name. The company name is written in a bold, sans-serif font, with the letters "TECH" slightly smaller and underlined.
Section 2 - Indications for Use Statement
Indication for use
(assigned by FDA Reviewer) 510K Number: K123940
Device Name: DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture
Indication for Use:
DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in superficial soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.
| Prescription Use | "X" | And/Or | Over the-Counter |
|---|---|---|---|
| Use(Part 21 CFR 801; Subpart D) | (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)
Peter L. Hudson -5 2014.05.30 10:56:41 -04'00'
2-1
§ 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.