(54 days)
The EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
The EndoGuide fits over a pediatric colonoscope and can be converted from a flexible to a rigid configuration on demand. The EndoGuide is back loaded onto the shaft of the colonoscope before the instrument is inserted into the patient. The device was designed to be activated by a vacuum source and needs to be connected to the existing vacuum line in the endoscopy suite. Application of vacuum causes the device to become rigid. In this "active" mode (vacuum on) the rigid insertion tube facilitates the passing of the colonoscope thru the insertion tube and resists colonoscope looping. In the "passive" mode (vacuum off) the insertion tube is very flexible and can be advanced deeper into the colon.
The provided text is a 510(k) summary for the EndoGuide device and does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data. The document states that the device is "substantially equivalent" to a predicate device, focusing on its functional characteristics and intended use.
Here's a breakdown of the available information and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "To support the substantial equivalence determination, a summary of the in-vitro testing to confirm the performance characteristics in comparison with the predicate device has been submitted." However, the actual table of acceptance criteria and the reported device performance from this in-vitro testing is NOT included in the provided text.
The document only notes the functional differences from the predicate device:
- The EndoGuide differs in that it is capable of becoming rigid when required by the physician. When rigid the device facilitates the passing of the endoscope thru the insertion tube and resists endoscopic looping. But when in its flexible state, the insertion tube is can be advanced into the colon.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. It only mentions "in-vitro testing" without details on sample size, or whether the data was retrospective or prospective, or country of origin.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. The 510(k) summary does not mention any expert review or ground truth establishment related to clinical performance metrics. The focus is on device function compared to a predicate.
4. Adjudication Method:
This information is not provided. Given that no expert review or ground truth establishment relevant to clinical performance is mentioned, an adjudication method would not be applicable in the provided context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported in this 510(k) summary. The device is a medical instrument (an overtube), not an AI or imaging diagnostic tool that would typically involve human reader performance comparisons.
6. Standalone Performance Study (Algorithm Only):
A standalone performance study was not conducted or reported. As mentioned, this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The document refers to "in-vitro testing to confirm the performance characteristics in comparison with the predicate device." This implies that the "ground truth" for the device's technical performance would be defined by engineering specifications and comparative functional assessments against the predicate device's established performance. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for this type of device in the provided summary.
8. Sample Size for the Training Set:
This information is not applicable and not provided. There is no "training set" as this device is a physical instrument, not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided as there is no training set for this type of device.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence of a physical medical device (EndoGuide) to a predicate device (Guardus™ Overtube) based on its operational characteristics and intended use. It explicitly mentions "in-vitro testing" for performance comparison but does not detail the specific acceptance criteria, test results, or methodology (like sample sizes, expert involvement, or ground truth establishment). It does not involve AI or diagnostic imaging algorithms, hence no MRMC or standalone algorithm performance studies are relevant or reported.
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SECTION 5 510(k) SUMMARY
| 510(k) Owner: KMS Medical LLC |
|---|
| 7290 SW 42nd Street |
| Miami, FL |
| 33155 |
| Tel: 305-266-3388 |
| Fax: 305-267-7589 |
JAN 3 1 2007
| Trade Name: | EndoGuide |
|---|---|
| Common Name: | EndoGuide Device |
| Classification Name: | Endoscope and Accessories |
| Classification Regulation: | 21 CFR 876.1500 |
| Class: | II |
| Product Code: | KOG |
| Predicate Device: | US Endoscopy Group, Guardus™ Overtube, K040836 |
| Device Description: | The EndoGuide fits over a pediatric colonoscope and canbe converted from a flexible to a rigid configuration ondemand. The EndoGuide is back loaded onto the shaft ofthe colonoscope before the instrument is inserted into thepatient. The device was designed to be activated by avacuum source and needs to be connected to the existingvacuum line in the endoscopy suite. Application ofvacuum causes the device to become rigid. In this "active"mode (vacuum on) the rigid insertion tube facilitates thepassing of the colonoscope thru the insertion tube andresists colonoscope looping. In the "passive" mode(vacuum off) the insertion tube is very flexible and can beadvanced deeper into the colon. |
| Intended Use: | The EndoGuide is intended to be used with an endoscope tofacilitate intubation, change of endoscopes, and removal ofmultiple polyps and/or foreign bodies. |
| Device Comparison: | The proposed device is similar to the US EndoscopyGuardus™ Overtube. Both devices have identicalindications for use. The EndoGuide differs in that it iscapable of becoming rigid when required by the physician.When rigid the device facilitates the passing of theendoscope thru the insertion tube and resists endoscopic |
·
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looping. But when in its flexible state, the insertion tube is can be advanced into the colon.
Performance Data: To support the substantial equivalence determination, a summary of the in-vitro testing to confirm the performance characteristics in comparison with the predicate device has been submitted.
Summary Prepared by:
Mario Arbesu Director of Product Assurance, KMS Medical LLC
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized feathers and wings.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mario Arbesu Director of Product Assurance KMS Medical LLC 7290 S.W. 42nd Street MIAMI FL 33155
JAN 3 1 2007
Re: K063654
Trade/Device Name: EndoGuide Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF and KOG Dated: December 6, 2006 Received: December 13, 2006
Dear Mr. Arbesu:
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.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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Page 2 -
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); 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.
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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SECTION 4 INDICATIONS FOR USE
X063654
510(k) Number (if known): TBD
Device Name: EndoGuide
Indications for Use:
The EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
Prescription Use V (Part 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 | K063654 |
KMS Medical EndoGuide 510(k) Submission
§ 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.