(114 days)
The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures.
The Endoscopic Monopolar Scissors is comprised of a flexible metal shaft with a distal mounted scissors which is operated by a proximal handle. The proximal handle also has connections for a monopolar electrocautery source. The scissor blades function as standard scissors for mechanical cutting and for standard electrosurgical cutting, as required.
The provided text describes the Endoscopic Monopolar Scissors and states that "Product testing was completed and met all of the acceptance criteria." However, it does not explicitly detail the acceptance criteria themselves or the specific results that demonstrate they were met. It only lists the types of testing performed.
Therefore, most of the requested information cannot be extracted from the provided document.
Here's what can be inferred/extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly detailed | Product testing was completed and met all of the acceptance criteria. |
| Dimensional | Met acceptance criteria (implied) |
| Visual | Met acceptance criteria (implied) |
| Atraumatic tip | Met acceptance criteria (implied) |
| Tortuous path | Met acceptance criteria (implied) |
| Handle pull strength | Met acceptance criteria (implied) |
| Resistivity | Met acceptance criteria (implied) |
| Electrocautery | Met acceptance criteria (implied) |
| Scissors performance | Met acceptance criteria (implied) |
2. Sample sized used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as the testing described is performance-based on the device itself, not requiring expert ground truth in the traditional sense of diagnostic accuracy studies.
4. Adjudication method for the test set
- Not applicable.
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
- No, this is a medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device.
7. The type of ground truth used
- The "ground truth" here would be the physical and electrical specifications/standards that the device needed to meet. The text doesn't specify these, but implies they exist (e.g., "acceptance criteria").
8. The sample size for the training set
- Not applicable, as this product is a physical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable.
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K090583
pg, of
JUN 26 2009
510(k) Summary
General Information
Classification
Trade Name
Submitter
Class II
Endoscopic Monopolar Scissors
Apollo Endosurgery, Inc. 7000 Bee Cave Road Suite 350 Austin, Texas 78746
Tel: (512) 328-9990
Contact
Greg Mathison Vice President Regulatory
Indications for Use
The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures.
Predicate Devices
TeleMed Systems Flexible Endoscopic Scissors K011412 TeleMed Systems Inc.
K063485 Logic Laparoscopic Monopolar Scissors Surgical Innovations Group
Device Description
The Endoscopic Monopolar Scissors is comprised of a flexible metal shaft with a distal mounted scissors which is operated by a proximal handle. The proximal handle also has connections for a monopolar electrocautery source. The scissor blades function as standard scissors for mechanical cutting and for standard electrosurgical cutting, as required.
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Materials
pg 2 of 2
All materials used in the manufacture of the Endoscopic Monopolar Scissors are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was completed and met all of the acceptance criteria. Testing included dimensional, visual, atraumatic tip, tortuous path, handle pull strength, resistivity, electrocautery and scissors performance.
Summary of Substantial Equivalence
The Endoscopic Monopolar Scissors is equivalent to the features of the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol. The symbol is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 2009
Mr. Gegory Mathison Vice President, Regulatory Affairs Apollo Endosurgery 7000 Bee Caves Road. Suite 350 AUSTIN TX 78746
Re: K090583
Trade/Device Name: Endoscopic Monopolar Scissors Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KGE Dated: June 15, 2009 Received: June 17, 2009
Dear Mr. Mathison:
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. Iisting 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 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 (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrb/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jarine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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/K0905.83
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Endoscopic Monopolar Scissors
The Apollo Endosurgery Endoscopic Monopolar Scissors are designed to cut, dissect, and cauterize tissue during flexible endoscopic procedures.
Prescription Use X (Per 21 CFR 801.109) OR
S 21
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)
Samual M. Mass
(Division Sign-Øff) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
Page 1 of 1
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).