(49 days)
Not Found
No
The description focuses on the mechanical function of the device for endoscopic suturing and tissue approximation. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is intended for "endoscopic placement of suture(s) and approximation of soft tissue" within the GI tract and peritoneal cavity, which are therapeutic medical procedures.
No
The device is described as an endoscopic suture system intended for tissue apposition, which is a therapeutic rather than a diagnostic function.
No
The device description and performance studies clearly indicate this is a hardware-based endoscopic suturing system with mechanical components and physical testing. There is no mention of software as the primary or sole component.
Based on the provided information, the Apollo Endosurgery OverStitch Endoscopic Suture System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic placement of suture(s) and approximation of soft tissue" within the GI tract and peritoneal cavity. This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the mechanical function of placing sutures and approximating tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The OverStitch system is a surgical tool used for tissue repair and approximation during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The Apollo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
Product codes
OCW, HCF
Device Description
The Apollo Endosurgery OverStitch Endoscopic Suture System provides physicians the ability to perform several different types of tissue apposition within the Gastrointestinal (GI) Tract and peritoneal cavity. Additionally, the system allows the surgeon to 'reload' the suture without the need for removing the endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Within the Gastrointestinal (GI) Tract and peritoneal cavity.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians
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)
Product testing was conducted to evaluate conformance to product specification. Testing included mechanical strength testing, bond strength, suture operation, suture securement and visual / dimensional inspection. Suture placement and securement testing was performed by comparing the OverStitch to commercially available predicate products. The products were used per their respective Instructions for Use. The results showed the OverStitch was equivalent to the predicate devices.
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
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.
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K081853 page 1/2
510(k) Summary
AUG 1 8 2008
General Information
Classification
Class II
Trade Name OverStitch
Submitter
Apollo Endosurgery, Inc. 7000 Bee Caves Road Suite 350 Austin, Texas 78746
Tel: (512) 328-9990
Contact
Dennis Mc Williams President & CEO
Intended Use
The Apollo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
Predicate Devices
| K061770 | Endoscopic Suturing System (ESS)
Ethicon Endo Surgery |
|---------|----------------------------------------------------------|
| K003956 | EndoCinch Suturing System
Davol / Bard |
| K972911 | Auto Suture-Endo Stitch
Tyco Healthcare |
Device Description
The Apollo Endosurgery OverStitch Endoscopic Suture System provides physicians the ability to perform several different types of tissue apposition within the Gastrointestinal
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K081893 page 2/2
(GI) Tract and peritoneal cavity. Additionally, the system allows the surgeon to 'reload' the suture without the need for removing the endoscope.
Materials
All materials used in the manufacture of the OverStitch are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification. Testing included mechanical strength testing, bond strength, suture operation, suture securement and visual / dimensional inspection.
Suture placement and securement testing was performed by comparing the OverStitch to commercially available predicate products. The products were used per their respective Instructions for Use. The results showed the OverStitch was equivalent to the predicate devices.
Summary of Substantial Equivalence
The OverStitch is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Apollo Endosurgery, Inc. % Mr. Dennis McWilliams President & CEO 7000 Bee Caves Road, Suite 350 Austin, Texas 78746
AUG 1 8 2008
Re: K081853
Trade/Device Name: OverStitch Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW, HCF Dated: June 26, 2008 Received: June 30, 2008
Dear Mr. McWilliams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced a bove 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 8C7); labeling (21 CFR Part 801); 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.
3
Page 2 - Mr. Dennis Mc Williams
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pretmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
OverStitch Endoscopic Suturing System
The Apollo Endosurgery OverStitch Endoscopic Suture System is intended for endoscopic placement of suture(s) and approximation of soft tissue.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Restorative.
(Division Sign-On) Restorative, Division of Neurological Devices
510(k) Number
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