(179 days)
Not Found
No
The summary describes a rigid, fiber-optic laparoscope for direct visualization and does not mention any AI or ML components or functionalities.
No.
This device is for illumination and direct visualization for diagnostic and surgical procedures, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures" and "for the purpose of diagnosis of diseases".
No
The device description explicitly states it is a "rigid, fiber-optic laparoscope," which is a physical hardware component.
Based on the provided information, the MIST Panoramic Laparoscope 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.
- MIST Panoramic Laparoscope Function: The description clearly states the device is used for "illumination and direct visualization of body cavities, hollow organs and canals during diagnostic and general surgical procedures." This involves examining structures inside the body directly, not analyzing samples taken from the body.
The device is a surgical instrument used for visualization during procedures performed on the patient, not a diagnostic test performed on samples from the patient.
N/A
Intended Use / Indications for Use
The MIST Panoramic Laparoscope 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 Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.
Product codes
GCJ
Device Description
The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. 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.
0
SEP 2 3 1997
Exhibit #1 510(k) Summary Page 1 of 2
510(K) Summary MIST Panoramic Laparoscope
150
Submitter Information:
m oli
Robert Hefter Vice President of Logistics Minimally Invasive 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
| Date 510(k) Summary Prepared: | March 27, 1997 |
|---|---|
| ------------------------------- | ---------------- |
Name of the Device:
| Trade or Proprietary Name: | MIST Panoramic Laparoscope, various
catalog numbers. |
|----------------------------|---------------------------------------------------------|
| Common Name: | Rigid Laparoscope |
Laparoscope, General and Plastic Surgery, Classification Name: Endoscope and Accessories, including instruments (21 CFR Part 876.1500)
1
Exhibit #1 510(k) Summary Page 2 of 2
ldentification of Legally Marketed Device to which the Submitter Claims Equivalence:
The MIST Panoramic Laparoscope is identical in intended use and materials to the Comeg Endoscopes marketed under K862275.
Description of the Subject Devices:
The MIST Panoramic Laparoscope is a rigid, fiber-optic laparoscope. 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 Panoramic Laparoscope 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 differences in the characteristics of the MIST Panoramic Laparoscope and the predicate devices. The MIST devices are identical to the predicate.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 2 3 1997
MIST c/o Ms. Carolann Kotula Official Correspondent MDI Consultants, Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Re: K971150
Trade Name: MIST Panoramic Laparoscope, a rigid laparoscope Regulatory Class: II Product Code: GCJ Dated: July 2, 1997 Received: July 7, 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 (OS) 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 dcvices), 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
4
510(k) Number (if known):
Device Name: Mist Panoramic Laparoscope
Indications For Use:
The MIST Panoramic Laparoscope is a rigid laparoscope intended for the illumination and direct visualization of body cavities, hollow organs and canals for the purpose of diagnosis of diseases and/or minimally invasive general surgeries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF HEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Genera
3100(k) Number
ue Device
16971150
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Options) Formal 1-2-96)