(30 days)
Not Found
No
The device description focuses on mechanical and vacuum-assisted tissue manipulation and stapling, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a surgical stapler used for tissue approximation and ligation, which is not considered a therapeutic device in the sense of treating a disease or condition itself, but rather a tool for a surgical procedure.
No
The device description clearly states it is a "surgical stapler used in hospitals or surgery centers for staple closure on the wall of the stomach or gastrointestinal tract," indicating a therapeutic rather than diagnostic function.
No
The device description clearly details a physical surgical stapler with a disposable head, reusable handle, and titanium staples. It also mentions the use of a vacuum pump, inflation syringes, and an endoscope, all of which are hardware components. There is no mention of software being the primary or sole component of this medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- Device Description: The BaroSense ACE Stapler is a surgical stapler used directly on tissue within the gastrointestinal tract for approximation and ligation. It is a surgical tool used for a procedure, not for analyzing a specimen.
- Intended Use: The intended use is for "endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract," which is a surgical procedure.
The device is a surgical instrument used in vivo (within the body), not in vitro (outside the body).
N/A
Intended Use / Indications for Use
The BaroSense ACE Stapler is indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.
The BaroSense ACE Stapler and Cartridge are indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract.
Product codes
OCW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals or surgery centers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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 Handle |
| BH8-01 ACE Stapler Head and Accessories | |
| BC8-01 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 Drive | |
| Redwood City CA 94063 | |
| Contact Person | Sheila Stevens, PhD |
| Director Clinical and Regulatory Affairs | |
| BaroSense, Inc. | |
| sstevens@barosense.com | |
| 650-362-6016 (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
1
Predicate Devices
| Manufacturer | Predicate device | 510(k) |
|---|---|---|
| BaroSense, Inc. | ||
| Redwood City, CA | F0084 ACE Stapler Reusable Handle | |
| F0085 ACE Stapler Head | ||
| F0086 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.
2
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
3
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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,
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
4
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.
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