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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the DAN Monopolar Lap Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance studies with specific statistical acceptance criteria.

Therefore, the requested information regarding acceptance criteria and the detailed study proving the device meets those criteria is not present in this document.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

Not applicable. The document states:
"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."
This implies that the acceptance criterion for the submission was demonstrating substantial equivalence, and the reported performance is that the device is substantially equivalent based on design analysis and comparison. Specific metrics or numerical targets are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No formal test set data for performance evaluation is mentioned. The submission relies on design analysis and comparison to predicate devices, not a new performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is mentioned.

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

Not applicable. This device (monopolar lap accessories) is a surgical instrument and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No formal ground truth was established for a performance study. The "ground truth" for this 510(k) would be the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. No machine learning or AI component, thus no training set.

9. How the ground truth for the training set was established

Not applicable. No machine learning or AI component, thus no training set or ground truth establishment for it.

In summary:

The 510(k) submission for DAN Monopolar Lap Accessories demonstrates substantial equivalence by comparing the design and basic functional characteristics of the new device to existing predicate devices. It does not present a new performance study with specific acceptance criteria, test sets, or ground truth as would be expected for a device relying on novel technology or diagnostic claims. The acceptance criterion for this submission was successful demonstration of substantial equivalence to already legally marketed devices.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

11 - 1994

K052759

		K052759
Date:	September 28, 2005
Submitter:	Name: Dannoritzer Medizintechnik GmbH & Co. KGAddress: Brenntenstr. 14Tuttlingen, Germany 78532Contact Person: Axel DannoritzerGeneral ManagerTelephone: +49.7461.72215Fax: +49.7461.161191
Product:	Trade Name: DAN Monopolar Lap Accessories
	Classification: Class IICommon Name: Laparoscope Accessories for General & Plastic SurgeryClassification 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:

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_

Regulation Number and Section

§ 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.