(225 days)
Not Found
No
The summary does not mention any AI or ML capabilities, image processing, or provide details about training or test sets, which are typical indicators of AI/ML in medical devices.
No
The device is described as an instrument for endoscopic sufascial dissection and fasciotomy, suggesting it is used for surgical or interventional procedures, which are considered therapeutic. However, it's explicitly stated to be a "telescope with working channel and outer sheath" for illumination and image transmission, and to introduce instruments. It primarily facilitates a therapeutic procedure rather than being therapeutic itself (e.g., providing treatment or therapy directly like a drug or a stimulator). Thus, it's a surgical tool used in a therapeutic context, not a therapeutic device itself.
No
No
The device description explicitly states it is a "telescope with working channel and outer sheath," which are physical hardware components.
Based on the provided information, the SEPS Videoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- SEPS Videoscope Function: The description clearly states the SEPS Videoscope is an instrument introduced into natural or artificial body cavities to illuminate them and transmit an optical image from inside the cavity. It is used for endoscopic procedures, which are performed within the body.
Therefore, the SEPS Videoscope is an in vivo (within the living body) medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SEPS Videoscope is a telescope with working channel and outer sheath for the endoscopic sufascial dissection of the venea perforantes and fasciotomy. The instrument is introduced into a natural or artificial body cavities to illuminate them and to transmit an optical image from inside the cavity. The working channel allows to introduce instruments into the cavity.
Product codes
GCJ
Device Description
The SEPS Videoscope is a telescope with working channel and outer sheath for the endoscopic sufascial dissection of the venea perforantes and fasciotomy. The instrument is introduced into a natural or artificial body cavities to illuminate them and to transmit an optical image from inside the cavity. The working channel allows to introduce instruments into the cavity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical image
Anatomical Site
natural or artificial body cavities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 1998
Mr. Glenn A. Dunki-Jacobs °Consultant The Altomec Corporation 400 Crenshaw Boulevard. Suite 109 Torrance, California 90503
Re: K972298
Trade Name: ETB Telescope W/Working Channel For Seps Regulatory Class: II Product Code: GCJ Dated: November 6, 1997 Received: November 12, 1997 -
Dear Mr. Dunki-Jacobs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent-determination assumes-compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
1
Page 2 - Mr. Dunki-Jacobs
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free " " number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices -Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ALTOMEC
400 Crenshaw Blvd., Ste. 109 Torrance, CA 90503 Tel: 310.782.9561 Fax: 310.782.9543
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | |
|---|---|
| Device Name: | ETB Telescope w/ Working Channel for SEPS |
| Indications For Use: | The SEPS Videoscope is a telescope with |
| working channel and outer sheath for the | |
| endoscopic sufascial dissection of the venea | |
| perforantes and fasciotomy. The instrument is | |
| introduced into a natural or artificial body | |
| cavities to illuminate them and to transmit an | |
| optical image from inside the cavity. The | |
| working channel allows to introduce | |
| instruments into the cavity. |
(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 General Restorative Devices | |
| 510(k) Number | K972298 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)