(173 days)
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.
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.
The provided text is a 510(k) Summary for the PMC Laparoscopic instruments. This document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device and does not raise new questions of safety and effectiveness.
Based on the nature of a 510(k) summary for conventional surgical instruments, the "acceptance criteria" and "study" described are focused on substantially equivalent performance to predicate devices rather than a clinical trial measuring diagnostic accuracy or treatment efficacy in the same way an AI/ML device would be evaluated.
Here's an analysis of the provided information in the context of your questions:
Description of Acceptance Criteria and the Study Demonstrating Device Performance:
The primary acceptance criterion for the PMC Laparoscopic instruments, as stated in the 510(k) summary, is substantial equivalence to existing legally marketed predicate devices (GIMMI ALPHA® Instruments & Accessories K012660 and MicroFrance Laparoscopic Manual Surgical Instruments K080257). This means demonstrating that the new device is as safe and effective as the predicates, and performs as well as or better than them, without raising new questions regarding safety and effectiveness.
The study proving the device meets this criterion is primarily a non-clinical performance evaluation consisting of:
- Bench testing: Performed on the PMC Laparoscopic instruments to demonstrate substantial equivalence to the predicate devices.
- Compliance with relevant standards: PMC certifies adherence to ISO/IEC/EN and other device-related standards.
- Biocompatibility testing:
- Electromagnetic compatibility (EMC) testing:
- Functionality testing:
- Safety testing:
These tests collectively aim to show that the PMC Laparoscopic instruments have similar design, technical characteristics, intended use, indications for use, sterilization methods, and material composition compared to the predicate devices. The summary explicitly states: "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."
Specific Information as Requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary of Study Findings) |
|---|---|
| Safety: Device presents no new safety risks compared to predicates. | Bench testing, biocompatibility, EMC, functionality, and safety testing confirm the product components are safe. |
| Effectiveness: Device performs its intended functions effectively. | Bench testing and functionality testing confirm the device performs as well as or better than predicate devices for scraping, cutting, grasping, holding, removing, manipulating tissue, and providing monopolar electrocautery. The device is "as effective" as the legally marketed device. |
| Functional Equivalence: Similar design, materials, and technical characteristics. | Detailed comparison table (page 2) shows similar dimensions (diameter, lengths), materials (stainless steel, carbon-fibre, insulation material), and components (scissors, forceps, connections, handles, sheaths, laparoscopes, light adapters, trocars, electrode, inserts) to the predicate devices. The document states they are "identical to the predicate devices" for the laparoscope and respective instruments. |
| Intended Use/Indications for Use Equivalence: Same clinical applications. | Explicitly stated that intended use and indications for use are similar to predicate devices. |
| Compliance with Standards: Adherence to established medical device standards. | PMC certifies compliance with relevant ISO/IEC/EN and other device-related standards. |
| Absence of New Questions of Safety and Effectiveness: No unanswered concerns arise. | The summary concludes that the data "do not raise any questions regarding safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. For non-clinical bench testing of surgical instruments, sample sizes are typically determined by engineering V&V protocols based on statistical significance for mechanical properties, material integrity, and functionality tests, rather than patient numbers or imaging data sets.
- Data Provenance: Not explicitly stated, but given the applicant and correspondent are German companies, it's highly probable the testing was conducted in Germany in a laboratory setting. This is retrospective in the sense that the device was fully developed and then tested against the defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For this type of device (conventional surgical instruments), ground truth is established by engineering specifications, material standards, and functional performance benchmarks rather than expert consensus on clinical data. The "ground truth" is the established performance of the predicate devices and relevant engineering standards.
- Qualifications of Experts: Not applicable in the context of clinical interpretation. The expertise would lie in engineering, materials science, and quality assurance professionals who designed and executed the bench tests and validated compliance with standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This document does not describe a process involving human adjudicators for "ground truth" establishment in a clinical context. The evaluation is based on objective measurements and compliance with predetermined technical specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not an AI/ML device or a diagnostic imaging device that would typically undergo such a study. The comparison is between the new device's physical and functional attributes and those of its predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a conventional manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used implicitly for substantial equivalence is primarily engineering specifications, material properties, functional performance benchmarks documented for the predicate devices, and international/national standards (ISO/IEC/EN) for medical devices (e.g., biocompatibility standards, electrical safety standards for electrocautery).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not use a training set as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. This device does not use a training set.
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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)
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>> 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 LaparoscopicinstrumentsNew device | MicroFrance LaparoscopicManual Surgical InstrumentsK080257 | GIMMI ALPHA®InstrumentsK012660 | |
|---|---|---|---|
| DiameterLengths | 5mm Tube,310mm/330mm/336mmvarious | 3mm to 12mm Tube, variousfrom 25cm to 60cm | 5mm Tube, various, from 25 cm to38 cm |
| Material | Stainless SteelCarbon-fibreInsulation material | Stainless SteelTungsten (Needle Holders)Insulation material | Stainless SteelInsulation material |
| Components | Scissors, Forceps,Connections, Handles,Sheaths, Laparoscopes, LightAdapters, Trocars, Electrode,and Inserts | Dismantable and Non-dismantableInsulated and non-insulatedForceps, Probes, NeedleHolders, Clamps, Dissectors,Scissors, Knife, Hook, KnotGuide, Retractors, and Blades | Dismantable and Non-dismantableInsulated and non-insulatedForceps, 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
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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
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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
§ 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.