The Digitex Delivery Device is a single-use device intended for use as an aid in suturing transvaginal pelvic organ prolapse procedures with surgical mesh.

Device Description

The Digitex® Suture Delivery System is composed of a 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 device has been designed to allow for adjusting the angle of the needle housing to further facilitate suture placement in the desired location.

AI/ML Overview

This document (K173527) is a 510(k) Premarket Notification for the Digitex Delivery Device, a specialized surgical instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for an AI/algorithm.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and MRMC studies for an AI device is NOT available in this document. The document describes non-clinical performance testing for a physical medical device.

However, I can extract the information relevant to the device's non-clinical performance testing and its acceptance (as stated in the document), though it's not structured in the way you asked for an AI/algorithm study.

Here's what can be extracted based on the provided text, rephrased to fit your prompt as much as possible, while clarifying that this is for a physical device, not an AI:

1. A table of acceptance criteria and the reported device performance

The document mentions that "The results of all performance testing met pre-defined acceptance criteria as applicable and are acceptable." However, the specific quantitative acceptance criteria or the raw performance data for each test are not detailed in this summary. It only states that the results met the criteria.

Performance Test	Acceptance Criteria	Reported Device Performance
Biocompatibility (Cytotoxicity, Sensitization, Irritation)	(Not specified in summary)	Met pre-defined acceptance criteria (Acceptable)
Sterilization Validation	(Not specified in summary)	Met pre-defined acceptance criteria (Acceptable)
Package Integrity (Simulated shipping and handling, Bubble leak testing, Seal strength testing)	(Not specified in summary)	Met pre-defined acceptance criteria (Acceptable)
Dimensional Analysis	(Not specified in summary)	Met pre-defined acceptance criteria (Acceptable)
Mechanical Performance Testing (evaluating key potential failure modes)	(Not specified in summary)	Met pre-defined acceptance criteria (Acceptable)
Shelf Life Testing	(Not specified in summary)	Met pre-defined acceptance criteria (Acceptable)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes non-clinical physical device testing. Sample sizes for these engineering tests and data provenance in terms of country of origin or retrospective/prospective nature are not specified in this 510(k) summary. These types of details would typically be found in the full test reports submitted to the FDA, not in the public 510(k) summary.

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)

This is not applicable to the non-clinical physical device testing described. The "ground truth" for these tests relates to engineering specifications and material standards, not expert medical consensus on diagnostic images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human readers or expert adjudication of medical cases.

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 document is for a physical surgical device, not an AI or imaging diagnostic tool. No MRMC study was performed or is relevant.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance tests is based on engineering specifications, material standards (e.g., ISO 10993-1 for biocompatibility), and pre-defined acceptance criteria for physical device performance (e.g., sterilization efficacy, package integrity, mechanical strength).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. No training set was used.

9. How the ground truth for the training set was established

Not applicable.

Summary

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February 12, 2018

Coloplast A/S Nikita Basandra Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411

Re: K173527

Trade/Device Name: Digitex Delivery Device Regulation Number: 21 CFR§ 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Regulatory Class: II Product Code: PWI Dated: November 13, 2017 Received: November 14, 2017

Dear Nikita Basandra:

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 or any Federal statutes and regulations administered by other Federal agencies.

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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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173527

Device Name Digitex Delivery Device

Indications for Use (Describe)

The Digitex Delivery Device is a single-use device intended for use as an aid in suturing transvaginal pelvic organ prolapse procedures with surgical mesh.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY - K173527

510(K) Owner's Name:	Coloplast A/S
Legal Manufacturer Address:	Holtedam 13050 Humlebaek, Denmark
Contact Person:	Nikita BasandraPrincipal Regulatory Affairs SpecialistPhone: (612) 505-8779 Email: usnbas@coloplast.com
Address/Contact:	1601 West River Road Minneapolis, MN 55411
Date Prepared:	February 12, 2018
Trade or Proprietary Name:	Digitex® Delivery Device
Common or Usual Name:	Instrumentation for use with urogynecologic surgical mesh
Classification Name:urogynecologic	Specialized surgical instrumentation for use withsurgical mesh
Classification Number:	21 CFR 884.4910
Product Code:	PWI (instrumentation, surgical mesh, urogynecologic,transvaginal repair of pelvic organ prolapse)
Device Class:	II
Classification Panel:	Obstetrics and Gynecology
Predicate Device:	The Digitex® Delivery Device is substantially equivalent inperformance, indication, design and materials to the CapioSLIM Suture Capturing Device, cleared under K172060 onNovember 3, 2017.The predicate device has not been subject to a design-relatedrecall.

Device Description:

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Intended Use of the device:

The Digitex Delivery Device is a single-use device intended for use as an aid in suturing during transvaginal pelvic organ prolapse procedures with surgical mesh.

Predicate Device Comparison:

The subject and predicate device have the same intended use - aid in the placement of urogynecologic surgical mesh.

The subject and predicate device have different technological characteristics including material composition and dimensions. These differences in technological characteristics do not raise different questions of safety and effectiveness.

Nonclinical Performance Testing:

The following non-clinical performance tests were performed on the subject device, per the special controls listed in 21 CFR 884.4910:

. Biocompatibility testing per ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process."
- o Cytotoxicity
- o Sensitization
- Irritation o
Sterilization validation
Package integrity testing ●
- Simulated shipping and handling o
- Bubble leak testing o
- Seal strength testing o
Dimensional analysis
Mechanical performance testing evaluating key potential failure modes ●
Shelf life Testing

The results of all performance testing met pre-defined acceptance criteria as applicable and are acceptable.

Conclusion

The results of the performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.

(a)
Identification. Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).(b)
Classification. Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible;
(2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed;
(3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life;
(4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh design that may be used with the device;
(ii) Detailed summary of the clinical evaluations pertinent to use of the device;
(iii) Expiration date; and
(iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.