ACE STAPLER, MODEL F0031

K082044 · Barosense, Inc. · OCW · May 11, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K082044
• Device Name: ACE STAPLER, MODEL F0031
• Applicant: Barosense, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: May 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

Device Story

Single-use, disposable surgical stapler; used in hospital/surgery settings by physicians. Device introduced trans-orally; utilizes flexible endoscope for visualization and vacuum pump to create tissue plication in GI tract. Mechanism: vacuum-assisted tissue capture; delivery of double, circular row of titanium staples with non-absorbable reinforcement ring. Output: secured tissue plication. Benefits: enables endoluminal tissue approximation/ligation for stomach or lower esophagus lesions.

Clinical Evidence

Bench testing and animal testing performed. All patient-contacting components tested for biocompatibility per ISO 10993. Testing yielded acceptable results confirming safety and effectiveness. No human clinical trial data reported.

Technological Characteristics

Single-use, disposable surgical stapler. Materials: biocompatible (ISO 10993 compliant), includes titanium staples and non-absorbable reinforcement ring. Principle: vacuum-assisted tissue plication with mechanical staple delivery. Form factor: endoscopic accessory for trans-oral use. Non-sterile supply (requires sterilization/sterile cartridge). No software or electronic algorithm.

Indications for Use

Indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract for patients requiring such procedures.

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

• StomaphyXTM Endoluminal Fastener and Delivery System (K062875)
• LSI Solutions Flexible Suture Placement Device (K011016)
• Plicator GSXTM Suturing System (K073671)

Submission Summary (Full Text)

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K082044 page 1 of 2

# 510(k) Summary of Safety and Effectiveness

MAY 1 1 2010

BaroSense ACE™ Stapler and Cartridge

BAROSENSE
INC.

## General Information

| Criteria | Information |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ACE™ Stapler<br>(Note: the trademark name is still being finalized<br>and may change from that listed above) |
| Product Name | ACE Stapler and Cartridge |
| Catalog/Model Number | Model #F0031 (Stapler)<br>Model #F0007 (Stapler Cartridge) |
| Common Name | surgical stapler and cartridge |
| Classification | 21 CFR 876.1500 - Endoscope and Accessories;<br>Endoscopic Tissue Approximation Device<br>Class II; Product code: OCW |
| 510(k) Owner | BaroSense, Inc.<br>3698-C Haven Ave.<br>Redwood City CA 94063 |
| Contact Person | Sheila S. Stevens, PhD<br>Director of Clinical Affairs<br>BaroSense, Inc.<br>[e-mail]<br>650-362-6000 (phone) 650-362-0700 (fax) |

## Summary of Substantial Equivalence

The BaroSense Inc., ACE Stapler and Cartridge (models F0031 and F0007) do not raise The Barboonse mor, I OE Stapis ues and are substantially equivalent to legally marketed delivery and fastener devices that are in commercial distribution, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976.

Date: March 5, 2010

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| Manufacturer | Substantially equivalent device | 510(k) |
|--------------------------------------------|---------------------------------------------------------|---------|
| EndoGastric Solutions, Inc.<br>Redmond, WA | StomaphyXTM Endoluminal Fastener<br>and Delivery System | K062875 |
| LSI Solutions<br>Rochester, NY | LSI Solutions Flexible Suture<br>Placement Device | K011016 |
| NDO Surgical, Inc.<br>Mansfield, MA | Plicator GSXTM Suturing System | K073671 |

## Substantially Equivalent Devices

### Device Description

The ACE™ Stapler is a single use, disposable, surgical stapler used in hospitals or surgery The NOD - Bupler is a single as a last anyall surface lesions on the wall of the stomach or lower esophagus.

The stapler is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. I he stapler is introduced into the patient through the mouth using a disposable In use, the supter is introuted into endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication visualization: "The GI tract, which is then held in place by means of a double, circular row of titanium staples delivered by the stapler (along with a non- absorbable ring to help reinforce the staple placement in the tissue).

The endogastric tube, flexible endoscope and vacuum pump used with the stapler are all The ondogative table medical devices and are not supplied with the stapler.

#### Indications for Use

The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.

#### Bench/Animal Testing

All patient contacting components of the ACE Stapler are composed of materials of known biocompatibility tested to the requirements of ISO 10993. The safety and Known blocompatibility tested to use r stablished through a series of bench and animal tests. All testing yielded acceptable results.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002

## MAY 1 1 2010

Sheila Stevens, Ph.D. Director, Clinical Affairs BaroSense, Inc. 3698-C Haven Avenue REDWOOD CITY CA 94063

· Re: K082044 Trade/Device Name: ACE™ Stapler Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW · Dated: March 5, 2010 Received: March 8, 2010

Dear Dr. Stevens:

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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOUaUY kyk 10+1

# Indications for Use Statement

510(k) Number (if known): K082044

Device Name: ACE™ Stapler

Indications for Use: The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. - - -

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082044

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