(79 days)
Not Found
No
The 510(k) summary describes a standard laparoscope for visualization and does not mention any AI/ML capabilities, image processing, or related performance metrics.
No
The device is described as a laparoscope intended for visualization during surgery, which is a diagnostic and observational function rather than a direct therapeutic intervention.
Yes
The device's intended use explicitly includes "Diagnosis and Management of acute abdomen," indicating its role in identifying medical conditions.
No
The device description explicitly states it is a "10MM diameter laparoscope," which is a physical hardware component used for visualization.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for visualization of the abdominal cavity during surgery. This is a direct surgical tool used in vivo (within the living body) for observation and guidance during procedures.
- Device Description: The description confirms it's a laparoscope, a surgical instrument used for viewing internal organs.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on specimens.
The device is a surgical instrument used for visualization during procedures, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Lerner Medical, Inc. Autoclavable 10MM Laparoscope is intended to be used for visualization of the abdominal cavity during general and thoracic surgery.
General Surgery
- Laparoscopic cholecystectomy, hernia repair, Appendectomy, Nissen fundal plication,
- Diagnosis and Management of acute abdomen
Thoracic Surgery - Pericardiectomy, Pneumonectomy, Evaluation of pulmonary nodule, Biopsy, Pleurodesis
Product codes
78GCJ, 85HET
Device Description
The Lerner Medical. Inc. Autoclavable 10MM Laparoscope System is a 10MM diameter laparoscope which may be used during diagnostic and operative laparoscopy procedures for visualization of the abouminaL cavity. The laparoscope may be disinfected using bigh level disinfectants or sterilized using ethylene oxide gas or steam autoclave.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity, thoracic cavity
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
OCT 2 9 1997
510(k) Notification: Lerner Medical, Inc. Autoclavable 10MM Diagnostic Laparoscope
SUMMARY OF SAFETY AND FIFFECTIVENESS Lerner Medical, Inc. Autoclavable 10MM Laparoscope
-
Name and Address of Applicant Lerner Medical, Inc. 840 West Main Street Lansdale, PA 19446 Contact: Michael Pollack President
-
Device Name and Classification
| Product Nomenclature | Classification
Number | Class | Regulation
Number |
|-----------------------------------------------|--------------------------|-------|----------------------|
| Laparoscope, General and
Plastic Surgery | 78GCJ | II | 21 CFR
§876.1500 |
| Laparoscope, Gynecological
and Accessories | 85HET | II | 21 CFR
§884.1720 |
Common/Usual Name:
Autoclavable I.aparoscopc
Trade/Proprictary Name:
Lerner Medical, Inc. Autoclavable 10MM
-
- Identification of Predicate Devices
Marketed Devices Used for Substantial Equivalence:
- Identification of Predicate Devices
The Lerner Medical, Inc. Autoclavable Laparoscope is substantially equivalcat to autoclavable laparoscopes marketed after May 28, 1976 and were determined as substantially equivalent by the US FDA. The Lemer Medical, Inc. Autoclavable 10MM Laparoscope is substantially equivalent to the following device; the Cuda Products Corporation Autoclavable Laparoscope (510(r): K935818)
- Device Description:
The Lemer Medical. Inc. Autoclavable 10MM Laparoscope System is a 10MM diameter laparoscope which may be used during diagnostic and operative laparoscopy procedures for visualization of the abouninal cavity. The laparoscope may be disinfected using bigh level disinfectants or sterilized using ethylene oxide gas or steam autoclave.
S. Intended Use of the Marketed Device:
The I emer Medical, Inc. Autoclavable 10MM Laparoscope is intended to be used for visualization of the abdominal cavity during general and thoracic surgery.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Pollack President Lerner LMI Medical, Inc. 840 West Main Street Lansdale, Pennsylvania 19446
OCT 29 1997
Re: K972984
Trade Name: Lerner Medical, Inc. Autoclavable 10 MM Laparoscope Regulatory Class: II ........ Product Code: GCJ Dated: August 4, 1997 Received: August 11, 1997
Dear Mr. Pollack:
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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Michael Pollack
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,
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
3
Pagc ( പ
510(k) Number (if known): _
Device Name: I cracr Medical, Inc. Autoclavable 10MM Laparoscope
Indications For Usc:
General Surgery
-
Laparoscopic cholecystectorny, liernia repair, Appendcctomy, Nissen fundal plication, . Diagnosis and Management of acute abdomen
Thoracic Surgery -
Pericardiectorny, Pneumonectomy, Evaluation of pulmonary nodule, Biopsy, Pleurodosis ●
(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 | K972984 |
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Uplional Format 1-2-96)