(42 days)
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No
The document describes standard surgical instruments and endoscopes without mentioning any computational or analytical capabilities beyond basic visualization and energy delivery. There is no mention of image processing, AI, ML, or any related concepts.
Yes
Explanation: The device is explicitly stated to be used for "therapeutic surgical procedures" and the bipolar electrodes "coagulate and to remove or destroy tissue," which are therapeutic functions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the arthroscope is indicated for "diagnosis of joint disease." While other components are for therapeutic procedures, the arthroscope component clearly has a diagnostic purpose.
No
The device description explicitly lists multiple hardware components such as surgical instruments, electrodes, endoscopes, and a light cable, all made of physical materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the devices as being used in vivo (within the body) for surgical procedures, visualization of organs and joints, and tissue manipulation (coagulation, removal). IVDs are used in vitro (outside the body) to examine specimens (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The description lists surgical instruments, endoscopes, electrodes, and accessories used directly on or within the patient. These are not components typically found in an IVD system.
- Lack of IVD-Specific Information: There is no mention of analyzing biological samples, reagents, or any of the typical processes associated with in vitro diagnostics.
The devices described are surgical instruments used for diagnostic and therapeutic procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
The Laparosopes and accessories are intended for use in providing access to and visualization of 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GEI
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Joints (knee, shoulder, wrist, temporal mandibular joint, ankle, elbow), various organs and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The devices conform to IEC 60601-2-2 and to the relevant provisions of European Device Directive 93/42/EEC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
0
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 Jung
Unterer Winkel 3
D-78573 Wurmlingen |
|--------------------------------------|-------------------------------------------------------------------|
| Contact Person | Harald Jung
Telefon +49 7461-96 92 36
FAX +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.
1
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.
2
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
4
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
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