(83 days)
The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.
The EndoLok™ is a non-sterile, single-use device designed to be used in conjunction with standard colonoscopes. It consists of a handle with a trigger mechanism that is used to grip the colonoscope shaft.
The provided text describes the EndoLok™ device and its review by the FDA. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance in the format requested, nor does it describe a study involving specific performance metrics, sample sizes, expert involvement, or AI.
Here's an analysis of what is available and what is missing:
Available Information:
- Device Name: EndoLok™
- Intended Use: "indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy."
- Predicate Device: EndoEase Advantage™ for Colonoscopy (K062805)
- Performance Data Summary: "Samples of the Syntheon LLC EndoLok™ were subjected to a 9-point bench test to demonstrate safety and effectiveness. All test samples met each test criterion. The device was determined to be safe and effective for its intended use."
- FDA Determination: Substantially Equivalent (SE) to the predicate device.
Missing Information (Crucial for requested table and study details):
- Specific Acceptance Criteria: The document states "All test samples met each test criterion" but does not list what those criteria were.
- Reported Device Performance against Criteria: Since the criteria aren't detailed, the specific performance values (e.g., specific grip strength in Newtons, precise friction coefficient, angular range) are also not provided.
- Details of the "9-point bench test": The nature of these 9 points is not elaborated upon.
- Sample size for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details (effect size, AI assistance).
- Standalone algorithm performance study details (AI without human-in-the-loop).
- Type of ground truth (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Based on the provided text, here's what can be deduced, and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Hypothetical, based on "non-slip grip" and "facilitate advancement, retraction, and angular orientation") | Reported Device Performance (as stated in the document) |
|---|---|
| Specific criteria are not detailed in the provided text. The document only states: "All test samples met each test criterion." | Specific performance metrics are not detailed. The document only states: "All test samples met each test criterion. The device was determined to be safe and effective for its intended use." |
| Example (if details were available): Minimum Grip Force to prevent slippage on colonoscope shaft. | Example (if details were available): Achieved >X Newtons, meeting the minimum. |
| Example (if details were available): Allowable angular orientation range. | Example (if details were available): Maintained angular orientation within X degrees of target. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document states "Samples of the Syntheon LLC EndoLok™ were subjected to a 9-point bench test." The exact number of samples is not provided.
- Data Provenance: The device manufacturer, Syntheon LLC, is based in Miami, Florida, USA. The testing was a "bench test," implying laboratory conditions rather than patient data from a specific country or clinical setting. It is inherently prospective as the device was manufactured and then tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This was a bench test of a physical medical device (a handle for a colonoscope), not an AI/imaging diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set:
- Not applicable / Not provided. As this was a bench test against predefined criteria, an adjudication method for conflicting expert opinions (as in image interpretation) would not be relevant. The "adjudication" was likely whether the test sample met the objective test criterion.
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 document describes a K080317 510(k) submission for a physical medical device (colonoscope handle), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical handle, not an algorithm. Therefore, standalone algorithm performance is not relevant or described.
7. The type of ground truth used:
- Objective Bench Test Criteria. The "ground truth" for this device's performance was whether it met the predefined technical specifications and performance characteristics established for the "9-point bench test." These would likely be engineering or physical metrics related to grip, force, durability, etc.
8. The sample size for the training set:
- Not applicable / Not provided. This device is a physical, non-AI medical device; therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for AI/ML model development.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no AI/ML training set, this question is not relevant.
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Summary of Safety and Effectiveness for the EndoLok™
K0803/7
submitted by Syntheon LLC 7290 SW 42 Street Miami, Florida 33155 Phone: (305) 969-4545
APR 2 9 2008
| Contact Person: | Carlos Rivera |
|---|---|
| Device Trade Name: | EndoLok™ |
| Common Name: | Colonoscope and accessories, flexible/rigid |
| Classification Name: | Endoscopic access overtube, gastroenterology-urology |
| Regulation Numbwe: | 21 CFR § 876.1500 |
Identification of a Legally Marketed Predicate Device
The Syntheon LLC EndoLok™ is substantially equivalent to EndoEase Advantage™ for Colonoscopy that is legally marketed and distributed by Spirus Medical, Inc. pursuant to premarket notification K062805.
Device Description
The EndoLok™ is a non-sterile, single-use device designed to be used in conjunction with standard colonoscopes. It consists of a handle with a trigger mechanism that is used to grip the colonoscope shaft.
Intended Use
The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.
Summary of Technological Characteristics
A 7-point comparison of technological characteristics of the Syntheon LLC EndoLokTM and the predicate devices was performed. The devices were found to be substantially equivalent.
Summary of Performance Data
Samples of the Syntheon LLC EndoLok™ were subjected to a 9-point bench test to demonstrate safety and effectiveness. All test samples met each test criterion. The device was determined to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Syntheon LLC % Mr. Al Weisenborn Official Correspondent KMS Medical LLC 7290 SW 42nd Street MIAMI FL 33155
APR 29 2008
Re: K080317
· Trade/Device Name: EndoLokTM Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: February 1, 2008 Received: February 6, 2008
Dear Mr. Weisenborn:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
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Protecting and Promoting Public Health
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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 Ant or any Federal statutes and regulations administered by other Federal agencies. You nort comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); 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 bectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 devices to Iv(all) marketed predicate device results in a classification for your device and thus, pormits 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) Of Crair of Compliance a one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please confact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Droweillance at 24/02/6 3474. For questions regarding the reporting of device adverse events (Medical Development) (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) 632-211 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/judex.html
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon . Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
08031 510(k) Number (if known):
Device Name: EndoLok™
Indications for Use:
The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K080317 |
Page 1 of 1
Syntheon LLC
Revised April 24, 2008
§ 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.