The ACETM Stapler is a surgical stapler used in hospitals or surgery centers for staple closure on the wall of the stomach or gastrointestinal tract. The single-patient-use, disposable stapler head is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. The stapler head is attached to a reusable, flexible stapler handle that controls the position and articulation of the stapler head. In use, the stapler is introduced into the patient through the mouth. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication (tissue fold) in the GI tract, which is then compressed. The stapler then places a double ring of titanium staples (8 staples). A non-absorbable ring helps reinforce the staple placement in the tissue. The tissue compression and stapling functions are controlled by commercially available inflation syringes. An endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The overtube, flexible endoscope, vacuum pump and inflation syringes used with the stapler are all commercially available medical devices, not the subject of this 510(k), and are not supplied with the stapler.

AI/ML Overview

This document describes the BaroSense ACE™ Stapler and Cartridge, a surgical stapler used for staple closure on the wall of the stomach or gastrointestinal tract. However, it does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text is a 510(k) summary for a medical device seeking substantial equivalence to a previously cleared predicate device.

Here's a breakdown of why the requested information is absent and what is provided:

Missing Information (and why it's missing from this type of document):

A table of acceptance criteria and the reported device performance: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on detailing specific performance acceptance criteria and results. Such criteria and results would typically be found in detailed test reports, not in this high-level summary.
Sample size used for the test set and the data provenance: Clinical study details are not typically provided in this type of 510(k) summary for a device seeking substantial equivalence based on bench and animal testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no human-read test set is described.
Adjudication method for the test set: Not applicable as no human-read test set is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a surgical stapler, not an AI-assisted diagnostic or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical stapler.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no human-read test set is described. Performance is based on physical and mechanical testing.
The sample size for the training set: Not applicable. This is a surgical stapler, not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "acceptance criteria" and "study":

The document states:

"All patient-contacting components of the ACE Stapler are composed of materials of known biocompatibility and tested to the requirements of ISO 10993 for the predicate device." This implies that biocompatibility is an acceptance criterion, and testing to ISO 10993 is the study demonstrating it.
"The only new material for the modified device is a white orientation marking on the flexible portion of the stapler handle. The new material has also been tested to the requirements of ISO 10993." This reinforces biocompatibility testing as an acceptance criterion for new materials.
"The safety and effectiveness of the device was further established through a series of bench and animal tests. All testing yielded acceptable results." This is a general statement that safety and effectiveness were verified through bench and animal studies, and the results were acceptable. It does not provide specific performance metrics or acceptance criteria beyond "acceptable results."

Summary of available information:

Criteria/Aspect	Information provided in the document
Acceptance Criteria & Reported Performance	- Biocompatibility: New and existing patient-contacting materials tested to ISO 10993 requirements. (Specific pass/fail values or reported performance metrics are not detailed in this summary, but the general statement is "tested to the requirements" and yielded "acceptable results".)- Safety and Effectiveness: Established through bench and animal tests. (Specific performance metrics and acceptance criteria for these tests are not detailed beyond "All testing yielded acceptable results.")- Substantial Equivalence: The primary "acceptance criteria" for K120147, as a 510(k), is substantial equivalence to the predicate device K110829 by demonstrating similar technological characteristics and indications for use, despite minor modifications (staple pattern, stapler head diameter, stapler handle diameter, longer articulation section). This is not a performance criterion in the typical sense, but rather a regulatory one.
Sample size (test set) & Data Provenance	Not specified for bench or animal tests. Data provenance is implied to be from BaroSense, Inc.'s internal testing.
Number of experts & qualifications for ground truth (test set)	Not applicable. No expert-based ground truth for a test set is described. Tests are physical/mechanical.
Adjudication method for test set	Not applicable.
MRMC comparative effectiveness study	Not applicable. This is a surgical stapler, not an AI/imaging device.
Standalone (algorithm only) performance study	Not applicable. This is a surgical stapler.
Type of ground truth used	Not applicable in the context of human expert review. Performance is assessed against engineering specifications, biocompatibility standards (ISO 10993), and functional performance in bench and animal models (though specific metrics not detailed in this summary).
Sample size for training set	Not applicable. This is a surgical stapler, not an AI/ML device.
How ground truth for training set was established	Not applicable.

In essence, the document serves as a regulatory summary to demonstrate substantial equivalence, not a detailed technical report on performance testing and acceptance criteria. It mentions "bench and animal tests" yielded "acceptable results" to establish safety and effectiveness, and new materials were "tested to the requirements of ISO 10993" for biocompatibility, but it does not elaborate on the specific acceptance criteria or the study details.

Summary

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III. 510(k) Summary

BaroSense ACE™ Stapler and Cartridge

Image /page/0/Picture/3 description: The image shows the logo for Barosense Inc. The logo features a stylized graphic to the left of the company name. The graphic appears to be an abstract design, possibly representing a person or a plant.

General Information

Criteria	Information
Trade Name	ACE TM Stapler and Cartridge
Product Name	ACE Stapler and Cartridge
Catalog/Model Number	BRH-01 ACE Stapler Reusable HandleBH8-01 ACE Stapler Head and AccessoriesBC8-01 ACE Stapler Cartridge
Common Name	surgical stapler and cartridge
Classification	21 CFR 876.1500- Endoscope and Accessories;Class II; Product code: OCW
510(k) Owner	BaroSense, Inc.250 Chesapeake DriveRedwood City CA 94063
Contact Person	Sheila Stevens, PhDDirector Clinical and Regulatory AffairsBaroSense, Inc.sstevens@barosense.com650-362-6016 (phone) 650-362-0070 (fax)

Summary of Substantial Equivalence

The BaroSense, Inc., ACE Stapler and Cartridge (component models BRH-01, BH8-01 and BC8-01) are substantially equivalent to the BaroSense ACE Stapler and Cartridge (component models F0084, F0085 and F0086).

Date: January 17, 2012

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Predicate Devices

Manufacturer	Predicate device	510(k)
BaroSense, Inc.Redwood City, CA	F0084 ACE Stapler Reusable HandleF0085 ACE Stapler HeadF0086 ACE Stapler Cartridge	K110829

Device Description

The ACETM Stapler is a surgical stapler used in hospitals or surgery centers for staple closure on the wall of the stomach or gastrointestinal tract.

The single-patient-use, disposable stapler head is supplied non-sterile and is fitted with a sterile, single-use staple cartridge. The stapler head is attached to a reusable, flexible stapler handle that controls the position and articulation of the stapler head. In use, the stapler is introduced into the patient through the mouth. A flexible endoscope passes through the stapler for gastric tissue visualization. The stapler works in conjunction with a vacuum pump to create a plication (tissue fold) in the GI tract, which is then compressed. The stapler then places a double ring of titanium staples (8 staples). A non-absorbable ring helps reinforce the staple placement in the tissue. The tissue compression and stapling functions are controlled by commercially available inflation syringes.

An endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The overtube, flexible endoscope, vacuum pump and inflation syringes used with the stapler are all commercially available medical devices, not the subject of this 510(k), and are not supplied with the stapler.

The predicate device has identical technological characteristics as the modified device. However, the predicate stapler device delivers a double ring of 10 staples, rather than 8. The change in staple pattern and other minor changes to the stapler head allow a smaller overall stapler head diameter compared to the predicate. The modified stapler handle also has a slightly smaller diameter and a longer articulation section than the predicate device.

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 and tested to the requirements of ISO 10993 for the predicate device. The only new material for the modified device is a white orientation marking on the flexible portion of the stapler handle. The new material has also been tested to the requirements of ISO 10993. The safety and effectiveness of the device was further established through a series of bench and animal tests. All testing yielded acceptable results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

Sheila Stevens, Ph.D. Director, Clinical and Regulatory Affairs BaroSense, Inc. 250 Chesapeake Drive REDWOOD CITY CA 94063

FEB 1 7 2012

Re: K120147

Trade/Device Name: ACE™ Stapler and Cartridge Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated: January 17, 2012 Received: January 18, 2012

Dear Dr. Stevens:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave and have 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 conimeres processified in accordance with the provisions of the Federal Food, Drug, de neces that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, dicrerers, mains 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 your device is exasellion na 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 r rease of advised that I Dril 3 issuanted or our device complies with other requirements of the Act that I DA has made a cond regulations administered by other Federal agencies. You must of any I cucrar sturates and regaranents, including, but not limited to: registration and listing Comply with an the Act 3 requirements, mere 801); medical device reporting (reporting of medical

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Page 2 -

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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Evanko

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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Statement of Indications for Use II.

510(k) Number (if known): $120147

Device Name: ACE™ Stapler and Cartridge

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

Prescription Use X (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)

Page

2/17/2012
(Division Sign-Off)

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uctive, Gastro-Renal, and

ACE Stapler Special 510(k) BAROSENSE, INC.

page 6 of 47

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.