neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US

K142903 · Neosurgical, Ltd. · GCJ · Nov 12, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K142903
• Device Name: neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
• Applicant: Neosurgical, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.

Device Story

The neoClose AutoAnchor Pack is a surgical instrument system used during endoscopic/laparoscopic procedures to facilitate soft tissue approximation. The system consists of absorbable AutoAnchors (absorbable suture attached to an absorbable polymeric anchor) pre-loaded onto a neoClose Driver. The device is used in conjunction with a neoClose Guide. The surgeon uses the driver to deliver the anchor through the abdominal wall layers into the abdominal cavity. The system is provided sterile (EtO). By enabling the placement of anchors through soft tissue, the device assists in closing surgical access sites or approximating tissues, potentially improving procedural efficiency and patient outcomes in minimally invasive surgery.

Clinical Evidence

Bench testing only. Biocompatibility evaluation conducted per ISO 10993 standards. No clinical data provided.

Technological Characteristics

System includes absorbable polymeric anchors and suture material. Driver is a mechanical delivery tool. Sterilization via Ethylene Oxide (EtO). Device is a permanent implant (anchor) and transient tissue-contacting device (driver).

Indications for Use

Indicated for patients undergoing endoscopic or laparoscopic surgery requiring soft tissue approximation via the delivery of absorbable AutoAnchors.

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

• neoClose Hasson (K123280)
• neoClose Universal (K131688)

Submission Summary (Full Text)

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

November 12, 2014

neoSurgical Ltd. Ms. Orla Brennan Quality Assurance/Regulatory Affairs Director Block 12 Galway Technology Park, Parkmore Galway, Ireland

Re: K142903

Trade/Device Name: neoClose Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 3, 2014 Received: October 6, 2014

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. 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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] 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

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### 2. Indications for Use Statement

510(k) Number:

Device Name:

neoClose

Indications for Use: neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.

Prescription Use__X_ (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 3. 510(k) Summary

## 510(k) Summary

#### l . SUBMITTER

neoSurgical Ltd. Block 12 Galway Technology Park, Parkmore, Galway, Ireland

Phone: [phone]

Contact Person: Orla Brennan Date Prepared: October 3[d, 2014

#### ll. DEVICE

Name of Device: neoClose AutoAnchor Pack Common or Usual Name: Suture Passer Classification Name: Endoscope and Accessories (21 CRF 876.1500) Requlatory Class: II Product Code: GCJ

#### III. PREDICATE DEVICE

neoClose Hasson and neoClose Universal (K123280; K131688) This predicate has not been subject to a design-related recall.

#### IV. DEVICE DESCRIPTION

The neoClose AutoAnchor Pack consists of absorbable AutoAnchors and neoClose Drivers. The neoClose AutoAnchor consists of an absorbable suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose 2 AutoAnchor Pack (NCAA2-U) and the neoClose 4 AutoAnchor Pack (NCAA4-U). The neoClose AutoAnchors and Drivers are provided sterile (EtO).

Each neoClose AutoAnchor is pre-loaded on a neoClose Driver. The neoClose Driver is used to deliver an AutoAnchor through the abdominal wall layers into the abdominal cavity for subsequent soft tissue approximation. The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide.

- V. INDICATIONS FOR USE
neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.

The Indications for Use statement for the neoClose AutoAnchor Pack is identical to the predicate device.

- VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the subject and predicate devices are used for the delivery of absorbable AutoAnchors into the abdominal cavity for subsequent soft tissue approximation. At a high level, the subject and predicate devices are based on the following same technological elements:

CONFIDENTIAL: DO NOT REPRODUCE WITHOUT PERMISSION FROM NEOSURGICAL

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- . Absorbable AutoAnchors are delivered into the abdominal cavity for subsequent approximation of tissue
- A neoClose Driver is used to deliver an AutoAnchor into the abdominal . cavity
- . The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide

The following differences exist between the subject and predicate devices:

- The modified neoClose Driver is stiffer than the predicate neoClose Driver ●
- The modified neoClose Driver has a revised tip design
- An alternative suture has been introduced for the neoClose AutoAnchor
- . The packaging has been modified

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility

A biological evaluation was conducted for the neoClose AutoAnchor Pack in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA.

The neoClose AutoAnchor is considered a permanent implant, while the neoClose Driver is considered tissue contacting for a duration that is less than 24 hours.

### Bench Testing

Bench Testing was conducted for the neoClose AutoAnchor Pack to demonstrate that it is at least as safe and effective as the predicate device.

#### VIII. CONCLUSIONS

The neoClose AutoAnchor Pack is considered substantially equivalent to the predicate device. It has the same intended use and does not raise new questions reqarding safety or effectiveness. It is considered at least as safe and effective as the predicate device when used in accordance with the Instructions for Use.