(197 days)
No
The summary describes a rigid, fiber-optic endoscope for direct visualization and illumination, with no mention of image processing, AI, ML, or related concepts.
No.
The device is described as an endoscope used for illumination and direct visualization during diagnostic and general surgical procedures, without mention of any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures" and "during general diagnostic procedures."
No
The device description clearly states it is a "rigid, two piece fiber-optic endoscope" and a "two piece, rigid, fiberoptic laparoscope," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures." This describes a device used in vivo (within the body) for direct observation.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
- Device Description: The description confirms it's a "rigid, two piece fiber-optic endoscope" used for visualization, not for analyzing biological samples.
Therefore, the MIST Micro Interchangeable Scope System™ falls under the category of a surgical or diagnostic endoscope used for direct visualization within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MIST Micro Interchangeable Scope System ™ is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures.
The MIST Micro Interchangeable Scope Systems are rigid, two piece fiber-optic endoscopes intended for the illumination and direct visualization of body cavities, hollow organs and canals during general diagnostic procedures.
Product codes
GCJ
Device Description
The MIST Micro Interchangeable Scope System ™ is a two piece, rigid, fiberoptic laparoscope. The universal eyepiece (MicroView Handle)) may be used with several variable sizes of shafts. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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.
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K 970937 Sept. 26, 1997
Exhibit #1 510(k) Summary Page 1 of 2
510(K) Summary MIST Interchangeable Scope System. ™
Submitter Information:
Robert Hefter Director of Operations Director of Operae Surgical Technologies (MIST) 3310 US 70 West Smithfield, NC 27577 Telephone Number: (919) 989-6478
510(k) Summary Prepared By:
Carolann Kotula MDI Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021 Telephone Number: (516) 482-9001
March , 1997 Date 510(k) Summary Prepared:
Name of the Device:
| Trade or Proprietary Name: | MIST Micro Interchangeable Scope
Systems ™, various catalog numbers. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Rigid Laparoscope |
| Classification Name: | Laparoscope, General and Plastic Surgery,
Endoscope and Accessories, including
instruments (21 CFR Part 876.1500) |
N
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Exhibit #1 510(k) Summary Page 2 of 2
Identification of Legally Marketed Device to which the Submitter Claims Equivalence:
The MIST electrosurgical is identical in intended use and materials to the Galileo Endoscope marketed by Galileo Electro-Optics Corporation under K962116.
Description of the Subject Devices:
The MIST Micro Interchangeable Scope System ™ is a two piece, rigid, fiberoptic laparoscope. The universal eyepiece (MicroView Handle)) may be used with several variable sizes of shafts. No working channel is provided.
The devices are re-usable, and will be sold non-sterile with instruction for cleaning, sterilization, and re-use.
Intended Use of the Subject Devices
The MIST Micro Interchangeable Scope System ™ is intended to be used by trained physicians for the illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures.
Technological Characteristics of the Subject Devices
There are no significant technological characteristic of the MIST electrosurgical probes and the predicate devices. The MIST devices are identical to the predicate except that it is a two piece device.
Image /page/1/Picture/11 description: The image shows a handwritten symbol or character that resembles a stylized lowercase letter 'u' connected to a loop or elongated 'l' shape. The stroke is uneven, suggesting it was written quickly or with a slightly unsteady hand. The character is presented in black against a white background, which emphasizes its form and makes it easily visible.
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" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
MIST c/o Ms. Carolann Kotula Official Correspondent MDI Consultants, Inc. 55 Northern Boulevard Great Neck, New York 11021
SEP 2 6 1997
K970937 Re:
Trade Name: Mist Micro Interchangeable Scope System™ Regulatory Class: II Product Code: GCJ Dated: July 1, 1997 Received: July 3, 1997
Dear Ms. Kotula:
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 (QS) 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
3
Page 2 - Ms. Carolann Kotula
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,
to colly
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
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510(k) Number (if known):
MIST Micro Interchangeable Scope System ™
Device Name:
Indications For Use:
The MIST Micro Interchangeable Scope Systems are rigid, two piece fiber-optic endoscopes intended for the illumination and direct visualization of body cavities, hollow organs and canals during general diagnostic procedures.
1
(PLEASE:DO NOT WEITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF HEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K970937 |
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | -------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Options) Formal 1-2-96)