NEOCLOSE HASSON, NEOCLOSE UNIVERSAL

K131688 · Neosurgical, Ltd. · GCJ · Jul 18, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131688
• Device Name: NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
• Applicant: Neosurgical, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 18, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Suture passer device for endoscopic/laparoscopic surgery; facilitates delivery of absorbable AutoAnchors through soft tissues for approximation. Two variants: neoClose Hasson (includes sealed trocar anchoring) and neoClose Universal (standard soft tissue approximation). Components include AccuGuide (delivery guide) and two AutoAnchors loaded on drivers. Surgeon operates device during procedure to place anchors; provides mechanical assistance for tissue closure. Benefits include simplified suture placement and secure tissue approximation. No electronic or software components.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by design verification bench testing and a previously completed GLP animal study for the predicate device (K123280).

Technological Characteristics

Manual surgical instrument; consists of AccuGuide, drivers, and absorbable AutoAnchors. Two configurations: Hasson (flexible sleeve, suture locks, two guide channels) and Universal (thumb grip, one guide channel). Non-powered, mechanical device. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing endoscopic or laparoscopic surgery requiring soft tissue approximation via 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 (K123280)

Submission Summary (Full Text)

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K131688 page 1/2

#### 3. 510(k) Summary

### 510(k) Summary -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

## JUL 1 8 2013

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

#### 510(k) Number

.

| Date Prepared | 7 June 2013 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | neoClose Hasson and neoClose Universal |
| Common Name | Suture passer |
| Classification Name | §876.1500 Product code GCJ<br>Endoscope and Accessories. |
| Device Classification | Class II |
| Device Panel | General and Plastic Surgery Devices |
| Predicate Device | neoClose (K123280) |
| Submitter | neoSurgical Ltd.<br>Block 12<br>Galway Technology Park,<br>Parkmore,<br>Galway,<br>Ireland<br>Ph: [phone] |
| Contact Person | Orla Brennan<br>Block 12<br>Galway Technology Park,<br>Parkmore,<br>Galway,<br>Ireland<br>Ph: [phone] |

#### Device Description

The neoClose device is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/ laparoscopic surgery. There are two neoClose product codes, neoClose Hasson and neoClose Universal, each consisting of an AccuGuide and two AutoAnchors loaded onto two Drivers.

The neoClose Hasson is designed to provide sealed anchoring of a laparoscopic trocar and suture placement for subsequent soft tissue approximation. The neoClose Universal is equivalent to the neoClose Hasson design in its method of soft tissue approximation but does not provide for sealed anchoring of a trocar. Soft tissue approximation is facilitated by delivering two AutoAnchors, through an AccuGuide with a Driver. The AutoAnchors and Drivers for both the neoClose Hasson and Universal are identical but the AccuGuides differ in construction. The Hasson AccuGuide features Suture Locks, a flexible Sleeve, and two Guide Channels while the Universal AccuGuide features a Thumb Grip and one Guide Channel.

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#### Intended Use

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

#### Summary of Technological Characteristics of Modified Device Compared to the Legally Marketed Predicate Device

The technical characteristics of the applicant device are substantially equivalent to the predicate device with respect to indications for use, product design, materials, packaging, labeling and sterilization methods.

#### Support of Substantial Equivalence

neoSurgical 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 device. neoClose (K123280). A detailed justification for substantial equivalence was completed which includes a side-by-side comparison of the product attributes of the applicant device and predicate device. Design Verification bench testing supports the performance of the neoClose device and demonstrates that it is at least as safe and effective as the predicate device, neoClose (K123280).

- . Intended Use
The neoClose components have the same intended use as the predicates.

- . Physical Characteristics
There are no technological differences between the neoClose device and the predicate devices (neoClose K123280) affecting intended use or safety and effectiveness.

- . Anatomical Sites The neoClose device and its predicates may be utilized in the same anatomical site.
- . Performance

Design Verification bench testing support the use of the neoClose device and demonstrate that it is at least as safe and effective as the predicate device, neoClose (K123280).

#### . Safety Characteristics

The GLP Animal Study completed with the predicate device demonstrates the safety and effectiveness of both the modified neoClose device and the predicate neoClose device (K123280), because an extension of shelf life is the only change to the design of the modified device. Design Verification bench testing also demonstrates that the modified device is at least as safe and effective as the predicate device, neoClose (K123280).

The neoClose device is substantially equivalent to the predicate device since it has the same intended use, does not raise new concerns regarding safety and effectiveness and is at least as safe and effective as the predicate device when used in accordance with the Instructions for Use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 18, 2013

neoSurgical, Limited % Orla Brennan Quality Assurance and Regulatory Affairs Director Block 12 Galway Technology Park, Parkmore Galway, Ireland

Re: K131688

Trade/Device Name: neoClose Hasson, neoClose Universal Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 07, 2013 Received: June 18, 2013

Dear Orla 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 mislcading.

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Orla Brennan

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

### Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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- Indications for Use Statement 2.

| 510(k) Number:<br>K131688 | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Device Name: | neoClose | | | |
| Indications for Use: | | The neoClose device is intended to facilitate the delivery of<br>absorbable AutoAnchors through soft tissues of the body<br>during endoscopic/ laparoscopic surgery. | | |
| Prescription Use______________________________________________________________________________________________________________________________________________________________<br>(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)

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131688