neoClose PDS

K173917 · Neosurgical, Ltd. · GCJ · Nov 8, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K173917
• Device Name: neoClose PDS
• Applicant: Neosurgical, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures.

Device Story

neoClose PDS Anchor is a surgical device for soft tissue or prosthetic material approximation. It consists of absorbable PDS (polydioxanone) sutures attached to absorbable polymeric anchors, pre-loaded on sterile neoClose Drivers. During open or laparoscopic surgery, the driver delivers the anchor through soft tissue into the abdominal cavity. Once placed, the sutures are tied to secure the tissue or prosthetic material. The device is intended for use by surgeons in clinical settings. It benefits patients by facilitating tissue approximation during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by in vitro and ex vivo bench testing demonstrating that physical properties are appropriate for the intended use and no adverse effects were introduced.

Technological Characteristics

Device consists of absorbable PDS sutures and absorbable polymeric anchors. Provided sterile via Ethylene Oxide (EtO). Delivery system uses a manual driver to pass anchors through tissue. No electronic components or software.

Indications for Use

Indicated for approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures in patients requiring such closure.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Kumar T-Anchors Hernia Set (K081366)
• neoClose (K142903)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

November 8, 2018

neoSurgical Ltd % Ms. Orla Brennan Ouality Assurance & Regulatory Affairs Director Block 12 Galway Technology Park Parkmore Galway, H91 E4YD Ireland

Re: K173917

Trade/Device Name: neoClose PDS Anchor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 26, 2018 Received: October 9, 2018

Dear Ms. Brennan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

# 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

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# Indications for Use

510(k) Number (if known) K173917

Device Name neoClose PDS Anchor

Indications for Use (Describe)

neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures.

Type of Use (Select one or both, as applicable):

| <span style="text-decoration: overline;">☒</span> Registration Use (Part 21 CFR 201.3 Subject to) |
|---------------------------------------------------------------------------------------------------|
| □ Over-The-Counter Use (21 CFR 201.3 Subject to) |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary For neoClose PDS Anchor

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the neoClose PDS Anchor

510(k) Number K173917

- l. SUBMITTER
neoSurgical Ltd. Block 12 Galway Technology Park, Parkmore, Galway, Ireland

Phone: [phone]

Contact Person: Orla Brennan Date Prepared: 01 December 2017

- ll. DEVICE
Name of Device: neoClose PDS Anchor Common or Usual Name: Suture Passer Classification Name: Endoscope and Accessories (21 CRF 876.1500) Requlatory Class: II Product Code: GCJ

#### |||. PREDICATE DEVICE

- 1. Kumar T-Anchors Hernia Set (K081366)
- 2. neoClose (K142903)

#### IV. DEVICE DESCRIPTION

The neoClose PDS device consists of absorbable PDS Anchors and neoClose Drivers. The PDS Anchor consists of an absorbable PDS suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose PDS Anchor x 2 (NCPDSX2-U) and the neoClose PDS Anchor x 4 (NCPDSX4-U). The neoClose PDS Anchors and Drivers are provided sterile (EtO).

The neoClose PDS Anchors are pre-loaded on neoClose Drivers, which are passed through soft tissue for subsequent soft tissue or prosthetic material approximation.

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#### V. INDICATIONS FOR USE

neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surqical procedures.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject and predicate devices are based on the following technological elements:

- . Anchors are delivered into the abdominal cavity using a delivery device, and the sutures are tied to achieve approximation
- A delivery device is used to deliver the Anchor into the abdominal . cavitv

The following differences exist between the subject and predicate devices:

- A long-term absorbable suture has been introduced for the neoClose . PDS Anchor. All other materials are identical to the neoClose predicate.
#### VII. Support of Substantial Equivalence

neoSurqical has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the neoClose device is substantially equivalent to the currently marketed predicate devices. The neoClose device components have the same intended use as the predicate devices identified. Results of testing have demonstrated that no adverse effects were introduced and the physical properties are appropriate for the intended use. In Vitro and Ex Vivo testing were completed.

#### VIII. CONCLUSIONS

The neoClose PDS Anchor is substantially equivalent to the predicate devices. It has the same intended use and does not raise new questions reqarding safety or effectiveness. It is considered substantially equivalent in safety and effectiveness to the predicate device when used in accordance with the Instructions for Use.