The ACE™ 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, circular row of titanium 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. The stapler may be introduced over a guidewire. If multiple plications are required, an endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The guidewire, 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

The BaroSense ACE Stapler and Cartridge underwent bench and animal testing to establish safety and effectiveness. The device's biological evaluation also conforms to ISO 10993-1:2009 for biocompatibility, ISO 11137-1:2006 for sterilization of healthcare products - radiation - Part 1, and ISO 11137-2:2006 for sterilization of healthcare products - radiation - Part 2. The report explicitly states that for each of these ISO standards, the test data demonstrated conformity and the standards themselves include acceptance criteria.

Here's a breakdown of the specific aspects you requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Test/Standard	Acceptance Criteria	Reported Device Performance
Material Biocompatibility (per ISO 10993-1:2009)	Patient contacting components composed of materials of known biocompatibility	All patient contacting components are composed of materials of known biocompatibility, meeting the requirements of ISO 10993. Test data demonstrated conformity to the requirements of this standard.
Sterilization - Radiation Part 1 (per ISO 11137-1:2006)	Standard defines acceptance criteria for radiation sterilization of healthcare products.	Test data for the device demonstrated conformity to the requirements of this standard. This standard includes acceptance criteria.
Sterilization - Radiation Part 2 (per ISO 11137-2:2006)	Standard defines acceptance criteria for radiation sterilization of healthcare products.	Test data for the device demonstrated conformity to the requirements of this standard. This standard includes acceptance criteria.
Bench/Animal Testing (General Safety and Effectiveness)	Acceptable results for safety and effectiveness through a series of bench and animal tests.	"All testing yielded acceptable results."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "a series of bench and animal tests" but does not specify the sample sizes for these tests. The country of origin for the data, whether it was retrospective or prospective, is also not provided in the given text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The evaluation mainly references compliance with recognized international standards (ISO) and general "bench and animal tests."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for test sets.

5. 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

There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study being performed, nor is there any mention of AI assistance or human reader improvement with AI in the provided text. This device is a surgical stapler, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. The BaroSense ACE Stapler is a medical device, not an algorithm or AI system. Its performance is inherent to its mechanical and material properties, and its functionality is directly operated by a human user (surgeon) with a flexible endoscope for visualization.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For biocompatibility and sterilization, the "ground truth" is adherence to the specifications and requirements defined within the referenced ISO standards (ISO 10993, ISO 11137-1, ISO 11137-2). For general safety and effectiveness, the document generally refers to "acceptable results" from bench and animal tests. No specific expert consensus, pathology, or outcomes data is detailed as the direct ground truth apart from the standards themselves.

8. The sample size for the training set

This question is not applicable as the device is a mechanical surgical stapler and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

Summary

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III. 510(k) Summary

JUN - 3 2011

BaroSense ACE™ Stapler and Cartridge

Image /page/0/Picture/4 description: The image shows the logo for Barosense Inc. The logo features a stylized figure with arms raised inside of a circle. The text "BAROSENSE" is to the right of the figure, with "INC." below it.

General Information

Criteria	Information
Trade Name	ACE™ Stapler(Note: the trademark name is still being finalizedand may change from that listed above)
Product Name	ACE Stapler and Cartridge
Catalog/Model Number	F0084 ACE Stapler Reusable HandleF0085 ACE Stapler HeadF0087 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 Affairs BaroSense, Inc.sstevens@barosense.com650-362-6016 (phone) 650-362-0070 (fax)

Summary of Substantial Equivalence

The BaroSense, Inc., ACE Stapler and Cartridge (component models F0084, F0085 and F0086) are substantially equivalent to the BaroSense ACE Stapler and Cartridge (component models F0031 and F0007).

Date: March 22, 2011

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Predicate Devices

Manufacturer	Predicate device	510(k)
BaroSense, Inc.Redwood City, CA	ACE Stapler, model F0031ACE Stapler Cartridge, model F0007	K082044

Device Description

The ACE™ 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, circular row of titanium 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.

The stapler may be introduced over a guidewire. If multiple plications are required, an endogastric overtube may be used to protect the esophageal tissues during repeated insertions of the device. The guidewire, 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. However, the predicate stapler device is provided as a single-patient-use, non-sterile, disposable unit. The predicate device is introduced through an overtube, as it does not include a membrane designed for guidewire introduction.

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 effectiveness of the device was further established through a series of bench and animal tests. All testing yielded acceptable results.

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Form Approved: OMB No. 0910-0120; Expiration Date: 8/31/10
Department of Health and Human ServicesFood and Drug Administration
STANDARDS DATA REPORT FOR 510(k)s( To be filled in by applicant )
This report and the Summary Report Table are to be completed by the applicant when submitting a 510(k) that refer-ences a national or international standard. A separate report is required for each standard referenced in the 510(k).
TYPE OF 510(K) SUBMISSION
Traditional	Special	Abbreviated
STANDARD TITLE 1
ISO 11137-1:2006 Sterilization of Health Care Products - Radiation- Part 1:
Please answer the following questions
Is this standard recognized by FDA 2 ?	Yes	No
FDA Recognition number 3	# 14-297
Was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510(k)?	Yes	No
Is a summary report 4 describing the extent of conformance of the standard used included in the 510(k)?If no, complete a summary report table.	Yes	No
Does the test data for this device demonstrate conformity to the requirements of this standard as it pertains to this device?	Yes	No
Does this standard include acceptance criteria?If no, include the results of testing in the 510(k).	Yes	No
Does this standard include more than one option or selection of tests?If yes, report options selected in the summary report table.	Yes	No
Were there any deviations or adaptations made in the use of the standard?If yes, were deviations in accordance with the FDA supplemental information sheet (SIS) 5 ?	Yes	No
Were deviations or adaptations made beyond what is specified in the FDA SIS?If yes, report these deviations or adaptations in the summary report table.	Yes	No
Were there any exclusions from the standard?If yes, report these exclusions in the summary report table.	Yes	No
Is there an FDA guidance 6 that is associated with this standard?If yes, was the guidance document followed in preparation of this 510k?	Yes	No
Title of guidance:
1 The formatting convention for the title is: [SDO] [numeric identifier][title of standard] [date of publication]2 Authority [21 U.S.C.,360d], www.fda.gov/cdrh/stdsprog.html3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm4 The summary report should include: any adaptations used to adapt to the device under review (for example, alternative test methods); choices made when options or a selection of methods are described; deviations from the standard; requirements not applicable to the device; and the name and address of the test laboratory or certification body involved in conformance assessment to this standard. The summary report Includes information on all standards utilized during the development of the device.5 The supplemental Information sheet (SIS) is additional information which is necessary before FDA recognizes the standard. Found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm6 The online search for CDRH Guidance Documents can be found at www.fda.gov/cdrh/guidance.html

{3}------------------------------------------------

Form Approved: OMB No. 0910-0120; Expiration Date: 8/31/10

Department of Health and Human Services
Food and Drug Administration

STANDARDS DATA REPORT FOR 510(k)s
(To be filled in by applicant)

This report and the Summary Report Table are to be completed by the applicant when submitting a 510(k) that refer- ences a national or international standard. A separate report is required for each standard referenced in the 510(k).

TYPE OF 510(K) SUBMISSION

	Traditional		Special		Abbreviated
--	-------------	--------------------------	---------	-------------------------------------	-------------	--------------------------

STANDARD TITLE¹	ISO 11137-2:2006 Sterilization of Health Care Products - Radiation- Part 2:
-----------------	-----------------------------------------------------------------------------

Please answer the following questions

	Yes	No
Is this standard recognized by FDA²?
FDA Recognition number³	# 14-225
Was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510(k)?
Is a summary report⁴ describing the extent of conformance of the standard used included in the 510(k)? If no, complete a summary report table.
Does the test data for this device demonstrate conformity to the requirements of this standard as it pertains to this device?
Does this standard include acceptance criteria? If no, include the results of testing in the 510(k).
Does this standard include more than one option or selection of tests? If yes, report options selected in the summary report table.
Were there any deviations or adaptations made In the use of the standard? If yes, were deviations in accordance with the FDA supplemental information sheet (SIS)⁵?
Were deviations or adaptations made beyond what is specified in the FDA SIS? If yes, report these deviations or adaptations in the summary report table.
Were there any exclusions from the standard? If yes, report these exclusions in the summary report table.
Is there an FDA guidance⁶ that is associated with this standard? If yes, was the guidance document followed in preparation of this 510k? Title of guidance:

¹ The formatting convention for the title is: [SDO] [numeric Identifier] [title of standard] [date of publication]

² Authority [21 U.S.C. 360d], www.fda.gov/cdrh/stdsprog.html

³ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/ search.cfm

⁴ The summary report should include: any adaptations used to adapt to the device under review (for example, alternative test methods); choices made when options or a selection of methods are described; deviations from the standard; requirements not applicable to the device; and the name and address of the test laboratory or certification body involved in conformance assessment to this standard. The summary report includes information on all standards utilized during the development of the device.

⁵ The supplemental information sheet (SIS) Is additional information which la necessary before FDA recognizes the standard. Found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/ search cfm

⁶ The online search for CDRH Guidance Documents can be found at www.fda.gov/cdrh/guidance.html

FORM FDA 3654 (9/07)

Page 1

PSC Graphics (301) 443-1020

・

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Form Approved: OMB No. 0910-0120; Expiration Date: 8/31/10
Department of Health and Human ServicesFood and Drug Administration
STANDARDS DATA REPORT FOR 510(k)s( To be filled in by applicant )

This report and the Summary Report Table are to be completed by the applicant when submitting a 510(k) that references a national or international standard. A separate report is required for each standard referenced in the 510(k).

TYPE OF 510(K) SUBMISSION

Traditional	Special	Abbreviated
-----------------------------------------------------------------------	-------------------------------------------------------------------	-----------------------------------------------------------------------

STANDARD TITLE 1
10993-1:2009 Biological evaluation of medical devices -- Part 1:Evaluation and testing (Biocompatibility)

Please answer the following questions

Is this standard recognized by FDA 2 ?	Yes	No
FDA Recognition number 3	#2-156
Was a third party laboratory responsible for testing conformity of the device to this standard identified in the 510(k)?	Yes	No
Is a summary report 4 describing the extent of conformance of the standard used included in the 510(k)?If no, complete a summary report table.	Yes	No
Does the test data for this device demonstrate conformity to the requirements of this standard as it pertains to this device?	Yes	No
Does this standard include acceptance criteria?If no, include the results of testing in the 510(k).	Yes	No
Does this standard include more than one option or selection of tests?If yes, report options selected in the summary report table.	Yes	No
Were there any deviations or adaptations made in the use of the standard?If yes, were deviations in accordance with the FDA supplemental information sheet (SIS) 5 ?	Yes	No
Were deviations or adaptations made beyond what is specified in the FDA SIS?If yes, report these deviations or adaptations in the summary report table.	Yes	No
Were there any exclusions from the standard?If yes, report these exclusions in the summary report table.	Yes	No
Is there an FDA guidance 6 that is associated with this standard?If yes, was the guidance document followed in preparation of this 510k?Title of guidance:	Yes	No

1 The formatting convention for the title is: [SDO] [numeric Identifier] certification body involved in conformance assessment to this
(title of standard) [date of publication] standard. The summary report includes information on all standards
2 Authority (21 U.S.C. 360d), www.fda.gov/cdrh/stdsprog.html utilized during the development of the device.
3 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/ 5 The supplemental information sheet (SIS) is additional information
search.cfm which is necessary before FDA recognizes the standard. Found at
4 The summary report should Include: any adaptations used to adapt http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/
to the device under review (for example, alternative test methods); search.cfm
choices made when options or a selection of methods are described; 6 The online search for CDRH Guidance Documents can be found at
deviations from the standard: requirements not applicable to the www.fda.gov/cdrh/guidance.html
device; and the name and address of the test laboratory or

FORM FDA 3654 (9/07)Page 1	PSC Graphics (301) 443-6500
--------------------------------	-----------------------------

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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

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

JUN - 3 2011

Re: K110829

Trade/Device Name: ACE Stapler and Cartridge, Models F0084, -85 and -86 Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated: April 28, 2011 Received: May 6, 2011

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

{6}------------------------------------------------

Page 2

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,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K110829 page loft

Statement of Indications for Use II.

510(k) Number (if known): K // 0829

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)

Helid Reum

Page 1 of 1

uctive, Gastro-Renal, and

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.