The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture.

The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.

Device Description

The Digitex SDS is composed of delivery device and suture cartridge and is designed for use by the physician to facilitate the consistent placement of suture when direct visualization is not possible and/or the anatomical location is difficult to reach. The shaft of the delivery device has been designed to allow for adjusting the angle of the needle housing to further facilitate suture placement in the desired location. The suture cartridges are provided pre-loaded with non-absorbable polypropylene, absorbable polydioxanone, or absorbable polyglycolic acid coated suture.

AI/ML Overview

The provided text describes a 510(k) summary for the Digitex Suture Delivery System (SDS) and associated FDA correspondence, focusing on the substantial equivalence of modifications to the suture cartridges. However, it does not explicitly detail acceptance criteria or a specific study proving the device meets numerical acceptance criteria in the way typically expected for performance metrics (e.g., sensitivity, specificity for diagnostic devices).

Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify numerical acceptance criteria for device performance. Instead, the acceptance criteria are implicitly related to demonstrating "substantial equivalence" to predicate devices, focusing on design specifications and safety.

Feature/Test	Acceptance Criteria (Implicit)	Reported Device Performance (Summary of Nonclinical Tests)
Device Function (Modifications to Suture Cartridges)	Meet established design specifications for the modified Digitex Suture Cartridges (adding polydioxanone and polyglycolic acid coated absorbable sutures).	Evaluated via design verification testing and simulated use tests in a cadaveric laboratory. Confirmed that the modified Digitex Suture Cartridges meet established design specifications and are substantially equivalent to the predicate polypropylene Digitex Suture Cartridges.
Biocompatibility	Acceptable biocompatibility profile for the proposed absorbable Digitex Suture Cartridges.	Predicate Digitex Suture Cartridges previously subjected to biocompatibility testing (K093112) with acceptable results, which apply to the proposed absorbable cartridges. Additional evaluation and testing were conducted, demonstrating an acceptable biocompatibility profile for the proposed absorbable Digitex Suture Cartridges.
Sterilization Method & Sterility Assurance Level (SAL)	Meet requirements of ISO 11135 and ISO 10993-7 for sterilization method, SAL, and modified sterile barrier.	The sterilization method and SAL have not changed. The change to the contract sterilization facility and modified sterile barrier have been evaluated and meet the requirements of ISO 11135 and ISO 10993-7.
Overall Equivalence	Demonstrate substantial equivalence to predicate devices (Digitex Suture Delivery System: K093112, Deknatel Deklene II suture, K930738; Monodek PDO suture, K030212; and Bondek PGA suture, K991191 & K992088) in intended use and fundamental scientific technology.	The Digitex Suture Delivery System is concluded to be substantially equivalent to the predicates, having the same intended use and fundamental scientific technology. The modifications were evaluated through design verification and simulated use tests, and additional biocompatibility and sterilization evaluations, all demonstrating fulfillment of established design specifications and equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Test Set: The document mentions "simulated use tests in a cadaveric laboratory" as part of the evaluation for the modified suture cartridges. However, it does not specify the sample size for this test set (e.g., number of cadavers, number of sutures placed).
Data Provenance: The simulated use tests were conducted in a "cadaveric laboratory." This implies human cadaveric tissue. The country of origin is not specified, but the applicant is from Denmark, and the contact is in the USA. Given this is a 510(k) submission to the FDA, it's likely testing was conducted to US standards. The study is retrospective in the sense that it's a controlled laboratory test, not an observational study of live patients over time.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish a "ground truth" in the context of diagnostic performance or clinical interpretation. The testing performed ("design verification testing and simulated use tests") focuses on the physical and functional performance of the device itself and its components. The judgment of whether "design specifications" are met would typically be done by engineers and quality control personnel, not clinical experts establishing ground truth for data interpretation.

4. Adjudication Method

Not applicable. Since there's no mention of expert evaluation of cases or data interpretation to establish a ground truth for performance metrics, there is no adjudication method described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a nonclinical, device-centric evaluation, not a study assessing human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical surgical tool (suture delivery system and cartridges), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" for this device revolves around its physical and functional performance meeting established design specifications for safety and efficacy in surgical use, and demonstrating substantial equivalence to predicate devices. This is assessed through:

Design verification testing: Verifying the device's physical properties, mechanical integrity, and functional operation.
Simulated use tests in a cadaveric laboratory: Demonstrating the device performs its intended function (suture delivery, passing a needle, holding suture) in a realistic anatomical setting.
Biocompatibility testing results: Ensuring the materials are safe for use in the human body.
Sterilization validation: Confirming the device can be sterilized effectively to prevent infection.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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7. 510(K) SUMMARY

MAY 2 3 2012

510(k) Owner/Submitter	Coloplast A/S; Division: Coloplast CorpHoltedam 1, Humlebaek 3050 - DenmarkFDA Establishment Registration Number: 2125050
Contact	Janell A. ColleyColoplast Corp1601 West River Road NorthMinneapolis, Minnesota 55411 USA
Date Prepared	30 January 2012
Common name/Classification(current/proposed)	Delivery Device: surgical instrument, 878.4800, Instrument, ligature passing and knottyingCurrent Suture Cartridge: surgical suture, 878.5010; Nonabsorbable polypropylenesurgical sutureProposed Suture Cartridge
Proprietary Name	Digitex Suture Delivery System (SDS); Digitex Delivery Device, Digitex SutureCartridge
Predicate Devices	Digitex System: Digitex Suture Delivery System: K093112Proposed Digitex Suture Cartridge predicates: Deknatel Deklene II suture, K930738;Monodek PDO suture, K030212; Bondek PGA suture, K991191 & K992088
Device Description	The Digitex SDS is composed of delivery device and suture cartridge and is designed for use by the physician tofacilitate the consistent placement of suture when direct visualization is not possible and/or the anatomicallocation is difficult to reach. The shaft of the delivery device has been designed to allow for adjusting the angle ofthe needle housing to further facilitate suture placement in the desired location. The suture cartridges areprovided pre-loaded with non-absorbable polypropylene, absorbable polydioxanone, or absorbable polyglycolicacid coated suture.
Intended Use	The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. Thedevice assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and knot-tying by holding the suture.The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.
Technological Characteristics Compared to Predicate	The Digitex Suture Delivery System has the same intended use and fundamental scientific technology as thepredicates Digitex Suture Delivery System: K093112, Deknatel Deklene II suture, K930738; Monodek PDO suture,K030212; and Bondek PGA suture, K991191 & K992088.
Summary Of The Nonclinical Tests Submitted	The modifications to the Digitex Suture Cartridges, specifically, adding suture cartridges with polydioxanone andpolyglycolic acid coated absorbable suture, were evaluated via design verification testing and simulated use tests ina cadaveric laboratory. These tests confirmed that the Digitex Suture Cartridges, as modified, meet the establisheddesign specifications and are substantially equivalent to the predicate polypropylene Digitex Suture Cartridges. Thepredicate Digitex Suture Cartridges were subjected to biocompatibility testing to support the original 510k (K093112)and acceptable results from this testing apply to the proposed absorbable Digitex Suture Cartridges; additionalevaluation and testing was conducted and acceptable results from this testing further demonstrate the acceptablebiocompatibility profile of the proposed absorbable Digitex Suture Cartridges. The sterilization method and sterilityassurance lever (SAL) have not changed; the change to the contract sterilization facility and modified sterile barrierhave been evaluated and meet the requirements of ISO 11135 and ISO 10993-7.
Summary Of Clinical Tests Submitted (As Applicable)	Not applicable

Conclusions Drawn From The Nonclinical Tests The Digitex Suture Delivery System is substantially equivalent to the predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized depiction of a human figure with outstretched arms, resembling a bird in flight. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Coloplast A/S % Ms. Janell Colley Regulatory Affairs Manager 1601 West River Road North Minneapolis, Minnesota 55411

2 3 2012

Re: K120284

Trade/Device Name: Digitex Suture Delivery System (SDS) Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: NEW,GAM Dated: April 20 . 2012 Received: April 23, 2012

Dear Ms. Colley

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. 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

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Page 2 - Ms. Janell Colley

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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6. STATEMENT OF INDICATIONS FOR USE .

510(k) Number (if known): K120284

Device Name: Digitex Suture Delivery System (SDS)

Indications for Use:

The Digitex Suture Cartridge holds sterile suture indicated for soft tissue approximation.

Prescription Use	X
------------------	---

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

AND/OR (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)

Daniel Keane for MM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120284

Coloplast Digitex Suture Delivery System Traditional 510(k) Digitex Absorbable Suture Cartridges Page 23 of 315

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.