(257 days)
Not Found
No
The document describes standard reusable laparoscopic surgical accessories (forceps, electrodes, etc.) and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on substantial equivalence to predicate devices based on basic functional characteristics.
No.
The device is described as an accessory for electrosurgical cutting and coagulation during laparoscopic procedures, and its intended use is for these procedures, not for therapeutic intervention in and of itself.
No
The document describes surgical instruments used for cutting and coagulation during laparoscopic procedures, not for identifying or classifying diseases or conditions.
No
The device description explicitly states it consists of physical components like handles, shafts, inserts (forceps, scissors, etc.), and electrodes, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation." This describes a surgical tool used on the patient during a procedure.
- Device Description: The description details surgical instruments like forceps, electrodes, and handles. These are physical tools used in surgery, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, GEI
Device Description
DAN Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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)
Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness.
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
§ 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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
11 - 1994
| K052759 | ||
|---|---|---|
| Date: | September 28, 2005 | |
| Submitter: | Name: Dannoritzer Medizintechnik GmbH & Co. KG | |
| Address: Brenntenstr. 14 | ||
| Tuttlingen, Germany 78532 | ||
| Contact Person: Axel Dannoritzer | ||
| General Manager | ||
| Telephone: +49.7461.72215 | ||
| Fax: +49.7461.161191 | ||
| Product: | Trade Name: DAN Monopolar Lap Accessories | |
| Classification: Class II | ||
| Common Name: Laparoscope Accessories for General & Plastic Surgery | ||
| Classification Name: Laparoscope, General & Plastic Surgery (GCJ, 21 CFR 876.1500) | ||
| Electrosurgical Cutting & Coagulation & Accessories (GEI, 21 CFR 878.4400) | ||
| Predicate Devices: | Miltex Laparoscopic Instruments, Miltex, Inc., K043013Laparoscopic Electrode, Megadyne Medical Products, K040699 | |
| Device Description: | DAN Monopolar Lap Accessories consist of Standard insulated monopolar handlesInsulated shaftsClass I inserts (forceps, scissors, biopsy cups, needle holders)Electrodes The device is reusable and provided non-sterile. It must be cleaned and | |
| sterilized before use. | ||
| Intended Use: | DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation. | |
| Performance Data: | Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness. | |
| Conclusion: | Based upon the product technical information provided, intended use and performance information provided in this premarket notification, DAN Monopolar Lap Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 14 2006
Dannoritzer Medizintechnik GmbH & Co. KG % Business Support International Ms. Angelika Scherp Amstel 320-I Amsterdam 1017AP
Re: K052759
Trade/Device Name: DAN Monopolar Lap Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 15, 2006 Received: May 18, 2006
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
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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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Hubert Lenoir
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number (if known): K052759
Device Name: DAN Monopolar Lap Accessories
Indications for Use:
DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
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)
Herbert Lehman
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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Kb52759 510(k) Number_