(173 days)
Not Found
No
The document describes standard laparoscopic instruments and procedures, with no mention of AI or ML capabilities.
Yes
Explanation: The device is used in therapeutic procedures and performs therapeutic functions such as cutting, scraping, grasping, removing, and manipulating tissue, as well as providing electrocautery to dissect and coagulate soft tissue. Its intended uses also include the treatment of ectopic pregnancy, pelvic tumors, and perforate abdominal organs.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that laparoscopes are used in "diagnostic procedures" or for "visualization and diagnosis" of various conditions like pelvic pain, infertility, ectopic pregnancy, pelvic tumors, endometriosis, and pelvic inflammatory disease.
No
The device description explicitly lists physical components such as scissors, forceps, handles, sheaths, laparoscopes, and trocars, and mentions materials like stainless steel and insulation, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used by surgeons in diagnostic and therapeutic procedures within the abdominal cavity for manipulating tissue, organs, and bowel. It also mentions providing electrocautery.
- Device Description: The description details components like scissors, forceps, laparoscopes, trocars, and electrodes, all of which are instruments used directly on or within the body during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of this device does not involve the analysis of such samples.
The device described is a surgical instrument used for direct intervention and visualization within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
PMC Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures as:
-unexplained pelvic pain (acute, chronic)
-infertility work-up
-tubal sterilization
-diagnosis and/or treatment of ectopic pregnancy
-evaluation, diagnosis and/or treatment of pelvic tumors, incl. myomata (less than 16 weeks gestational size)
-Retrieval of foreign bodies
-determination of the presence and extent of pelvic endometriosis
-determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
-access to abdomen for surgical procedures such as LAVH
-visualization, diagnosis and/or treatment of perforate abdominal organs
The PMC Laparoscopic instruments contain different components such as scissors, forceps, connections, handles, sheaths, laparoscopes, light adapters, trocars, electrode, and inserts. The instruments are made out of martensitic stainless steel, a standard material for medical devices, and insulation material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Non-clinical performance data:
PMC certifies compliance with relevant ISO/IEC/EN and other device-related standards. Moreover bench testing has been performed on the PMC Laparoscopic instruments to demonstrate that the device is substantially equivalent to the predicate devices.
Summary:
The presented data that was conducted on the PMC Laparoscopic instruments shows in its results and in comparison to the predicate devices that the product is safe, as effective, and performs as well as or better than the legally marketed device, therefore do not raise any questions regarding safety and effectiveness. The product components which are covered by this 510(k) premarket notification have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows the text "K101193" at the top, followed by the letters "PMC" in a bold, stylized font. Below "PMC" is the text "Medical GmbH" in a smaller, sans-serif font. The text and letters are all black against a white background.
>> 510(k) Summary as required by section 807.92
04/15/2010
OCT 1 8 2010
Submission Applicant: PMC Medical GmbH Gerhard Mondrowski Nelblingstraße 10 78573 Wurmlingen / Germany Phone: +49-7461-1407370 Fax: +49-7461-1407390 E-mail: info@pmc-medical.com
Establishment Registration Number: 3006986250
Application Correspondent/Contact: think! Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany Phone: +49-7462-924 051 Fax: +49-7462-924 128 E-mail: andrea@thinkworks.biz
>> Device Identification:
Trade name: PMC Laparoscopic instruments
Common name: Laparoscopes / Endoscopes
Classification name: Laparoscope, general & plastic surgery, Endoscope and accessories, Review Panel General & Plastic Surgery (21 CFR 876.1500, GCJ)
l
>> Predicate Device Information:
510(k)-Number: K012660, GIMMI ALPHA® Instruments & Accessories Firm: GIMMI GMBH
510(k)-Number: K080257, MicroFrance Laparoscopic Manual Surgical Instruments Firm: MEDTRONIC XOMED, INC.
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Image /page/1/Picture/0 description: The image shows the logo for PMC Medical GmbH. The logo consists of the letters "PMC" in a bold, sans-serif font, with the letters slightly overlapping each other. Below the letters, the words "Medical GmbH" are written in a smaller, sans-serif font.
>>Description of the Device:
PMC Laparoscopes provide illumination and visualization in diagnostic procedures and in conjunction with laparoscopic instruments (accessories) operative laparoscopic procedures as:
-unexplained pelvic pain (acute, chronic)
-infertility work-up
-tubal sterilization
-diagnosis and/or treatment of ectopic pregnancy
-evaluation, diagnosis and/or treatment of pelvic tumors, incl. myomata (less than 16 weeks gestational size)
-Retrieval of foreign bodies
-determination of the presence and extent of pelvic endometriosis
-determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
-access to abdomen for surgical procedures such as LAVH
-visualization, diagnosis and/or treatment of perforate abdominal organs
The PMC Laparoscopic instruments contain different components such as scissors, forceps, connections, handles, sheaths, laparoscopes, light adapters, trocars, electrode, and inserts. The instruments are made out of martensitic stainless steel, a standard material for medical devices, and insulation material.
>>Indications for Use:
Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.
>> Technological characteristics compared to the Predicate Devices:
The PMC Laparoscopic instruments are similiar to the Gimmi and Medtronic Xomed products in terms of design, technical characteristics, intended use, indications for use, sterilization, and components of devices. The Laparoscope and the respective laparoscopic instruments are identical to the predicate devices. The PMC product is also similiar to the Gimmi and Medtronic Xomed products in terms of the used material.
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Image /page/2/Picture/0 description: The image shows the logo for PMC Medical GmbH. The logo consists of the letters "PMC" in a bold, sans-serif font, with the letters slightly overlapping. Below the letters, the words "Medical GmbH" are written in a smaller, sans-serif font.
| | PMC Laparoscopic
instruments
New device | MicroFrance Laparoscopic
Manual Surgical Instruments
K080257 | GIMMI ALPHA®
Instruments
K012660 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diameter
Lengths | 5mm Tube,
310mm/330mm/336mm
various | 3mm to 12mm Tube, various
from 25cm to 60cm | 5mm Tube, various, from 25 cm to
38 cm |
| Material | Stainless Steel
Carbon-fibre
Insulation material | Stainless Steel
Tungsten (Needle Holders)
Insulation material | Stainless Steel
Insulation material |
| Components | Scissors, Forceps,
Connections, Handles,
Sheaths, Laparoscopes, Light
Adapters, Trocars, Electrode,
and Inserts | Dismantable and Non-
dismantable
Insulated and non-insulated
Forceps, Probes, Needle
Holders, Clamps, Dissectors,
Scissors, Knife, Hook, Knot
Guide, Retractors, and Blades | Dismantable and Non-dismantable
Insulated and non-insulated
Forceps, Probes, Needle Holders,
Clamps, Dissectors, Scissors,
Knife, Hook, Knot Guide,
Retractors, Divers and Blades |
>> Non-clinical performance data:
PMC certifies compliance with relevant ISO/IEC/EN and other device-related standards. Moreover bench testing has been performed on the PMC Laparoscopic instruments to demonstrate that the device is substantially equivalent to the predicate devices.
>>Summary:
ז
The presented data that was conducted on the PMC Laparoscopic instruments shows in its results and in comparison to the predicate devices that the product is safe, as effective, and performs as well as or better than the legally marketed device, therefore do not raise any questions regarding safety and effectiveness. The product components which are covered by this 510(k) premarket notification have been successfully tested for biocompatibility, electromagnetic compatibility, functionality and safety according to international standards.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
PMC Medical GmbH % think! Ms. Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany
OCT 1 8 2010
Re: K101193
Trade/Device Name: PMC Laparoscopic instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 13, 2010 Received: September 16, 2010
Dear Ms. Pecsi:
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 (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Andrea Pecsi
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
K101193 OCT 1 8 2010
510(k) Number (if known): K101193
Device Name: PMC Laparoscopic instruments
Indications for Use:
Laparoscopes are used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Neil R.P. Doyle for mxm
vision Sign-( Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101193