(42 days)
The Laparosopes and accessories are intended for use in providing access to and visualization of organs, and canals to perform various diagnostic and therapeutic surgical procedures.
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.
The Hans Hermann Laparoscopes and accessories consists of
- uls Hermann Daparoped surgical instruments with and without monopolar high frequency connection
- bipolar electrodes and accessories -
- monopolar electrodes and accessories -
- monopolar cicchrodos and accessories, Verres needles and suction-/irrigation systems,
- several Endoscopes (Laparoscope, Arthroscope, Cystoscope) -
- and a light cable -
The body contact portions of the Laparoscopes and accessories are composed of The body comace stainless steel, PTFE, PEEK, several coatings, silicon and brass surgical grade stamicss stock, in medical devices for a wide range of chiromutin placer which is commonly of biocompatibility for human use at short term contact.
The provided document is a 510(k) summary for Laparoscopes and accessories (K051610) from Hermann Medizintechnik GmbH, submitted to the FDA in 2005.
Based on the provided text, the device relies on substantial equivalence to predicate devices rather than a direct performance study against specific acceptance criteria. This means the manufacturer is asserting that their device is as safe and effective as other legally marketed devices and does not present new questions of safety or effectiveness.
Therefore, the requested information regarding acceptance criteria, performance data from a specific study, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not explicitly available in this 510(k) submission.
Here's a breakdown of what can be inferred or stated as explicitly absent from the provided text, in response to your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined for a specific performance study. The core "acceptance" is based on substantial equivalence to predicate devices. | The devices conform to IEC 60601-2-2 and to the relevant provisions of European Device Directive 93/42/EEC. (This indicates compliance with general electrical safety and medical device directives, not specific clinical performance metrics). |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable (N/A) – No specific performance study with a test set is detailed in the document.
- Data provenance: N/A – No specific clinical data from a prospective or retrospective study is presented. The conformity to IEC and EEC directives implies compliance with standards, not necessarily clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A – No specific performance study with a ground truth established by experts is detailed.
4. Adjudication method for the test set
- N/A – No specific performance study with adjudication is detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not reported. This device is a surgical instrument (laparoscope), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not reported. This device is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A – The concept of "ground truth" as typically used in AI/diagnostic device studies does not directly apply to this 510(k) for a surgical instrument that relies on substantial equivalence for regulatory clearance. Compliance with safety standards (IEC, EEC) serves as the "truth" for device manufacturing and basic function.
8. The sample size for the training set
- N/A – No specific training set for an algorithm is mentioned or applicable.
9. How the ground truth for the training set was established
- N/A – No specific training set for an algorithm is mentioned or applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The document does not describe a clinical study in the traditional sense with specific acceptance criteria related to a performance metric. Instead, the "study" proving the device meets the (implied) acceptance criteria of safety and effectiveness for substantial equivalence consists of:
- Comparison to Predicate Devices: The manufacturer asserts that "Hermann Medizintechnik GmbH Laparoscopes and accessories are substantial equivalent to the predicate and others [devices], since the basic features, design and intended uses are the same. The major assessments of safety and effectiveness... raise no new questions as function or intended use of the devices." This is the primary "proof" for substantial equivalence.
- Compliance with Standards: The manufacturer states, "The devices conform to IEC 60601-2-2 and to the relevant provisions of European Device Directive 93/42/EEC." This indicates that the device has met established international and European safety and performance standards for medical electrical equipment.
In essence, for this 510(k), the "acceptance criteria" are implied to be fulfilled by demonstrating substantial equivalence to already cleared devices and by showing compliance with recognized safety and quality standards, rather than through a dedicated clinical performance study with predefined metrics.
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K051610
.JUL 29 2005
1/2
Hermann Medizintechnik GmbH Württemberger Str. 26 D-78567 Fridingen Germany
510(k) Summery of Safety and Effectiveness
Titel: Laparoscopes and accessories
April 08, 2005
| Submitted by | Ing.-Büro JungUnterer Winkel 3D-78573 Wurmlingen |
|---|---|
| Contact Person | Harald JungTelefon +49 7461-96 92 36FAX +49 7461-96 92 37 |
| Trade Name | Laparoscopes and accessories |
| Common Name | Laparoscopes |
| Product Code and Classification Name | GCJ, Laparoscope, General & Plastic Surgery |
| Product Classification | 21 CFR § 876.1500 |
Device Description
The Hans Hermann Laparoscopes and accessories consists of
- uls Hermann Daparoped surgical instruments with and without monopolar ﺖ high frequency connection
- bipolar electrodes and accessories -
- monopolar electrodes and accessories -
- monopolar cicchrodos and accessories, Verres needles and suction-/irrigation systems,
- several Endoscopes (Laparoscope, Arthroscope, Cystoscope) -
- and a light cable -
The body contact portions of the Laparoscopes and accessories are composed of The body comace stainless steel, PTFE, PEEK, several coatings, silicon and brass surgical grade stamicss stock, in medical devices for a wide range of chiromutin placer which is commonly of biocompatibility for human use at short term contact.
Intended Use
The Laparosopes and accessories are intended for use in providing access to and I he Laparosopos and accessorsegans, and canals to perform various diagnostic and therapeutic surgical procedures.
The arthroscope is indicated for illumination during joint examinations, arthroscopies, The artiff oscope is minimally invasive in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow. silouder, whist (ourpar tamies by the organiate and to remove or destroy tissue by the use of bipolar HF current.
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K051610 2/2
Substantial Equivalence
Substantial Equivalente
The Laparoscopes and accessories are substantial equivalent to the predicate and I he Laparoscopes and accessories and others, since the basic features, design and Ackermann, ASAF, Nichard Wolf and Sticles, ces between the Laparoscopes and intended uses are the same. The mator assess of safety and effectiveness, as as accessories and the predicate devices raise no now as function or intended use of the devices.
Performance Data
I criormance Data.
The devices conform to IEC 60601-2-2 and to the relevant provisions of European Device Directive 93/42/EEC.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around the perimeter of the circle. The text is in all capital letters.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2005
Hans Herman GmbH c/o Mr. Stefan Preiss TÜV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112
Re: K051610
Trade/Device Name: Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, GCJ Dated: July 20, 2005 Received: July 26, 2005
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) the article the arredicate devices marketed in interstate for use stated in the encrosule) to regally manced producal Device Americal Device Ameral Food. Drug commerce prior to May 28, 1970, the enactified in accordance with the provisions of the Federal Food, Drug, devices that have been reciassince in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the Act . Th and Cosmetic Act (Act) that to hot require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general controls pro You may, merelore, market the devices, sayes to the go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Feet merclass required.
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 If your device is classified (see above) into ensier as a consider of the subject can be may be subject to such additional controller controls. Extransmily on one In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to B.B. be found in the Code of Peachar Regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuates of a succession in the requirements of the Act
that FDA has made a determination that your device complies with on your must that FDA has made a decermination administered by other Federal agencies. You must or any Federal statures and regulations daminding, but not limited to: registration and isting (21 l comply with an the Act 3 requirements, me, good manufacturing practice requiremes as set CFR Part 807), labeling (21 CFR Part 801), good and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
{3}------------------------------------------------
Page 2 - Mr. Stefan Preiss
This letter will allow you to begin marketing your device as described in your Section 510(k)
The start of the support of any of a lot stick spivalence of your device to a le This letter will allow you to begin marketing your article of your device of your device to a legally
premarket notification. The FDA finding of substantial equivale and thu premarket notification. The PDA inding of substantial equively of your device ﻴﻦ ﻣﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the may be and any and 10, 276 0115 - Also, massa note the regulation en If you desire specific advice for your uevice on our nooming the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation contact the Office of Complialice at (240) 270 - 197 Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarkst nothleading the Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638-200 other general intornation on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Assistance at to to to to to to to consideration of the more of index.html.
Sincerely yours,
Stupt Rurda
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Right
Left
Laparoscopic instruments Device Name:
Indications For Use:
Indications For Use:
The Laparosopes and accessories are intended for use in providing access to and visualization of The Laparosopes and accessories are interious for assumes and therapeutic surgical procedures.
procedures.
The arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and The arthroscope is indicated on indimlation uning John oxantinables, and the knee, shoulder, wrist (capal
diagnosis of joint disease in minilly invasive only one olbow draghosis of joint disodoo ill mandibular joint, ankle and elbow.
tunnel syndrome), temporal mandibular joint, ankle remove on
tunnel syndrome), temporal mandibular joint, ankle and elser.
The bipolar electrodes are use to coagulate and to remove or destroy tissue by the use of bipolar HF current.
Prescription Use yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hyt Rueda
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051610
Page 1 of _1
§ 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.