Digitex Delivery Device

K173527 · Coloplast A/S · PWI · Feb 12, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K173527
• Device Name: Digitex Delivery Device
• Applicant: Coloplast A/S
• Product Code: PWI · Obstetrics/Gynecology
• Decision Date: Feb 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4910
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Digitex Delivery Device is a single-use surgical instrument designed to assist physicians in placing sutures during transvaginal pelvic organ prolapse procedures involving surgical mesh. The device consists of a delivery system and a suture cartridge. It is specifically intended for scenarios where direct visualization is limited or the anatomical site is difficult to access. The device features an adjustable needle housing angle on the shaft to facilitate precise suture placement. Operated by a physician in a clinical/surgical setting, the device aids in the consistent placement of sutures, potentially improving procedural efficiency and patient outcomes by ensuring secure mesh attachment.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1: cytotoxicity, sensitization, irritation), sterilization validation, package integrity (simulated shipping, bubble leak, seal strength), dimensional analysis, mechanical performance testing of failure modes, and shelf-life testing. All results met pre-defined acceptance criteria.

Technological Characteristics

Single-use surgical instrument; includes delivery device and suture cartridge. Features adjustable needle housing angle. Biocompatibility per ISO 10993-1. Sterilization validated. Mechanical performance testing conducted per 21 CFR 884.4910 special controls.

Indications for Use

Indicated for use as an aid in suturing during transvaginal pelvic organ prolapse procedures with surgical mesh.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Capio SLIM Suture Capturing Device (K172060)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.

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) |
|-------------------------------------------------|
|-------------------------------------------------|

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 1<br>3050 Humlebaek, Denmark |
| Contact Person: | Nikita Basandra<br>Principal Regulatory Affairs Specialist<br>Phone: [phone] Email: [e-mail] |
| 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:<br>urogynecologic | Specialized surgical instrumentation for use with<br>surgical mesh |
| Classification Number: | 21 CFR 884.4910 |
| Product Code: | PWI (instrumentation, surgical mesh, urogynecologic,<br>transvaginal repair of pelvic organ prolapse) |
| Device Class: | II |
| Classification Panel: | Obstetrics and Gynecology |
| Predicate Device: | The Digitex® Delivery Device is substantially equivalent in<br>performance, indication, design and materials to the Capio<br>SLIM Suture Capturing Device, cleared under K172060 on<br>November 3, 2017.<br>The predicate device has not been subject to a design-related<br>recall. |

### 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.

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Image /page/4/Picture/0 description: The image shows the Coloplast logo. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue on the right. The circular graphic is made up of several horizontal lines that are stacked on top of each other.

### 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.