(662 days)
Not Found
No
The device description focuses on mechanical stapling and vacuum assistance, with no mention of AI/ML terms or functionalities.
No.
The device is a surgical stapler used for tissue approximation and ligation, which are procedural actions, not therapeutic treatments in themselves.
No
The device is described as a surgical stapler used for tissue approximation and ligation in the gastrointestinal tract, indicating a therapeutic or interventional purpose, not diagnostic.
No
The device description clearly outlines a physical, single-use surgical stapler with a sterile cartridge, introduced via an endogastric tube, and working in conjunction with a vacuum pump and endoscope. This involves significant hardware components and mechanical action, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The BaroSense ACE Stapler is a surgical stapler used within the body (endoluminal) to approximate and ligate tissue in the gastrointestinal tract. It is a therapeutic device used for a surgical procedure, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states "endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract," which describes a surgical intervention.
Therefore, the BaroSense ACE Stapler falls under the category of a surgical device, not an In Vitro Diagnostic device.
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.
Product codes (comma separated list FDA assigned to the subject device)
OCW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
stomach
lower esophagus
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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 |
| (Note: the trademark name is still being finalized | |
| and may change from that listed above) | |
| Product Name | ACE Stapler and Cartridge |
| Catalog/Model Number | Model #F0031 (Stapler) |
| Model #F0007 (Stapler Cartridge) | |
| Common Name | surgical stapler and cartridge |
| Classification | 21 CFR 876.1500 - Endoscope and Accessories; |
| Endoscopic Tissue Approximation Device | |
| Class II; Product code: OCW | |
| 510(k) Owner | BaroSense, Inc. |
| 3698-C Haven Ave. | |
| Redwood City CA 94063 | |
| Contact Person | Sheila S. Stevens, PhD |
| Director of Clinical Affairs | |
| BaroSense, Inc. | |
| sstevens@barosense.com | |
| 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
1
| Manufacturer | Substantially equivalent device | 510(k) |
|---|---|---|
| EndoGastric Solutions, Inc. | ||
| Redmond, WA | StomaphyXTM Endoluminal Fastener | |
| and Delivery System | K062875 | |
| LSI Solutions | ||
| Rochester, NY | LSI Solutions Flexible Suture | |
| Placement Device | K011016 | |
| NDO Surgical, Inc. | ||
| 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes across its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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
3
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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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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