(71 days)
Not Found
Not Found
No
The summary describes standard endoscopic instruments and accessories with no mention of AI/ML capabilities, image processing, or data-driven performance metrics.
No
The device is described as "Endoscopic (Minimally Invasive) Instruments and Accessories" used for various endoscopic procedures, which implies a surgical or interventional role rather than direct therapy application.
No
The device description indicates that the instruments are for "various endoscopic procedures" and include surgical tools like forceps and electrodes, which are used for intervention or surgery, not for diagnosing a condition.
No
The device description explicitly lists physical instruments and accessories such as forceps, electrodes, and cables, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "various endoscopic procedures." Endoscopic procedures are performed in vivo (within the living body) to visualize and/or manipulate internal structures.
- Device Description: The device description lists instruments like forceps, electrodes, and cables, which are tools used directly on or within the patient during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (outside the body) to diagnose a condition. IVDs typically involve reagents, analyzers, and tests performed on biological specimens.
Therefore, the RZ Endoscopic (Minimally Invasive) Instruments and Accessories are surgical instruments used for procedures performed directly on the patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and include both electrical and non-electrical accessories.
Product codes
GEI
Device Description
RZ Endoscopic (Minimally Invasive) Instruments and Accessories consist of 1. Modular Forceps (reusable) 2. Single-Piece Forceps 3. Modular Forceps with Disposable Tips 4. Electrodes 5. Resectoscopic Instruments & Electrodes (reusable & disposable) 6. Electrosurgical Cables
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Testing was performed to support substantial equivalence to the predicate devices. The RZ Endoscopic (Minimally Invasive) Instruments and Accessories met all specified design and performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
K 08 2902
Page 1 of 2
. :
:
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
:
: 上一篇: 上一篇:
| Date: | December 2, 2008 | DEC 10 2008 |
|---|---|---|
| Submitter: | Name: RZ MEDIZINTECHNIK GmbH | |
| Address: Unter Hasslen 20 | ||
| 78532 Tuttlingen | ||
| Germany | ||
| Contact Person: Rainer Zubrod | ||
| Telephone: +49.7462.947010 | ||
| Fax: +49.7462.947050 | ||
| Product: | Trade Name: RZ Endoscopic (Minimally Invasive) Instruments and Accessories | |
| Classification: Class II | ||
| Common Name: Electrosurgical Instruments and Accessories | ||
| Classification: - Electrosurgical Cutting & Coagulation Device & Accessories | ||
| Name: - Endoscopic Grasping/Cutting Instrument, Non-Powered | ||
| Predicate Device: | Predicate devices are manufactured by Jakoubek Gmbh Ackermann Instrumente GmbH Gimmi GmbH Pajunk GmbH Sutter Medizintechnik GmbH Guenter Bissinger Medizintechnik GmbH | |
| Device Description: | RZ Endoscopic (Minimally Invasive) Instruments and Accessories consist of 1. Modular Forceps (reusable) 2. Single-Piece Forceps 3. Modular Forceps with Disposable Tips 4. Electrodes 5. Resectoscopic Instruments & Electrodes (reusable & disposable) 6. Electrosurgical Cables | |
| Intended Use: | RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and include both electrical and non-electrical accessories. | |
| Performance Data: | Testing was performed to support substantial equivalence to the predicate devices. The RZ Endoscopic (Minimally Invasive) Instruments and Accessories met all specified design and performance requirements. | |
| Sterilization | The single-use resectoscope electrodes and modular tips are offered sterile by ethylene oxide sterilization. All remaining devices are offered non-sterile for autoclave |
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Page 2 of 2
steam sterilization by user.
Conclusion:
Based upon the product technical information provided, intended use and performance information provided in this premarket notification, as well as similarity to legally marketed devices, RZ Endoscopic (Minimally Invasive) Instruments and Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is black and composed of thick, curved lines. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA". The text is arranged in a circular fashion around the eagle.
Public Health Service
DEC 10 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RZ Medizintechnik GmbH % Business Support International Ms. Angelika Scherp Amstel 320-I Amsterdam 1017AP Netherlands
Re: K082902
Trade/Device Name: RZ Endoscopic (Minimally Invasive) Instruments and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 29, 2008 Received: September 30, 2008
Dear Ms. Scherp:
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 such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Angelika Scherp
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson . 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):
KO82902 Device Name: RZ Endoscopic (Minimally Invasive) Instruments and
Accessories Indications for Use: RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and
include both electrical and non-electrical accessories.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogden-Grinton
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K092902