(54 days)
Not Found
No
The device description focuses on mechanical functionality (flexible to rigid conversion via vacuum) and does not mention any computational or data-driven processes characteristic of AI/ML. The "Mentions AI, DNN, or ML" field is also "Not Found".
No
The device facilitates intubation, change of endoscopes, and removal of polyps and foreign bodies, but it does not directly treat a disease or medical condition. It is a tool used during medical procedures.
No
The description of the EndoGuide indicates its function is to facilitate procedures (intubation, change of endoscopes, removal of polyps/foreign bodies) by providing support and rigidity to a colonoscope, rather than to diagnose medical conditions or identify diseases.
No
The device description clearly describes a physical device that fits over a colonoscope and changes rigidity based on a vacuum source. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used with an endoscope to facilitate procedures within the body (intubation, changing endoscopes, removing polyps/foreign bodies). This is an in-vivo procedure, not an in-vitro test.
- Device Description: The description details a physical device that fits over an endoscope and is inserted into the patient's colon. It manipulates the flexibility of the insertion tube. This is a medical device used for a procedural purpose, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostics.
Therefore, the EndoGuide is a medical device used for a procedural purpose within the body, not an in-vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
KOG, FDF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
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.
0
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 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. | |
| Intended 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. | |
| Device Comparison: | The proposed device is similar to the US Endoscopy |
| Guardus™ Overtube. Both devices have identical | |
| indications for use. 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 |
·
1
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
2
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
3
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
4
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