The pure Wrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

Device Description

The pureWrist™ electrocautery laparoscopic instruments are sterile, single use disposable instruments for use through appropriately sized surgical trocars. The instruments consist of a rotating insulated shaft with a 5mm diameter. The distal end of the shaft has the respective end effector attached (scissors, dissector, or hook). The proximal end of the shaft is attached to an ergonomically shaped handle with a rotating knob that allows the shaft to rotate 360 degrees in either direction. The handle contains the actuation mechanism for the respective end effector. The lever on the handle is compressed and released to activate the instrument jaws or scissor blades. Each instrument has a monopolor cautery connector that extends from the bottom of the handle. The connector is used for electrosurgery when properly attached to a standard cautery cable and proper generator.

AI/ML Overview

The Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments underwent preclinical testing to demonstrate substantial equivalence to the predicate device, Ethicon Endo-Surgery, Inc. ENDOPATH® Endoscopic Instruments (K984240).

Here's an overview of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Ergonomics of the handle and rotating knob	Studies demonstrated acceptable reliability and design performance relative to the predicate device.
Tissue trauma	Studies demonstrated acceptable reliability and design performance relative to the predicate device.
Grasping and dissecting ability	Studies demonstrated acceptable reliability and design performance relative to the predicate device.
Electrical insulation requirements	Studies demonstrated acceptable reliability and design performance relative to the predicate device.
Overall safety and effectiveness for intended use (grasping, mobilization, dissection, and transection of tissue in minimally invasive procedures)	The preclinical testing supported that the device can be used as designed and achieved acceptable reliability and design performance, leading to a determination of substantial equivalence to the predicate device.

2. Sample Size and Data Provenance

The document states "Pre-clinical testing was used to evaluate performance to ensure that the device can be used as designed." However, specific sample sizes for this testing are not provided in the given text.

The data provenance (country of origin, retrospective or prospective) is also not specified. Given it's preclinical testing for a medical device in the US, it's highly likely the testing was conducted in a controlled laboratory setting within the US and would be considered prospective in nature for a new device.

3. Number of Experts and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. The testing involved evaluating ergonomics, tissue trauma, grasping/dissecting ability, and electrical insulation, suggesting engineers, material scientists, and potentially clinicians (e.g., surgeons) would have been involved in assessing performance.

4. Adjudication Method

The document does not describe any adjudication method (e.g., 2+1, 3+1). Preclinical testing often relies on objective measurements and established standards, with consensus among the testing team, rather than a formal adjudication process as seen in clinical trials with human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. For a surgical instrument like this, the focus is on its functional performance and safety.

6. Standalone Performance (Algorithm Only)

This point is not applicable as the device is a physical electrocautery laparoscopic instrument, not an AI algorithm. Its performance is always in conjunction with a human surgeon.

7. Type of Ground Truth Used

The ground truth used for this preclinical testing would have been based on:

Engineering specifications and design requirements: Ensuring the device met its intended mechanical and electrical properties.
Established industry standards: For electrical insulation, tissue interaction, and ergonomic design relevant to surgical instruments.
Comparison to predicate device performance: The acceptability was determined "relative to the predicate device," implying the predicate's known performance characteristics (e.g., its ability to grasp, dissect, and cut tissue effectively and safely) served as a benchmark.
Qualitative assessment by experts: For aspects like ergonomics and ease of use, direct assessment by engineers or clinical users would have contributed.

8. Sample Size for Training Set

This question is not applicable as the device is a physical instrument and does not involve AI or machine learning models that require training data.

9. How Ground Truth for Training Set was Established

This question is not applicable as there is no training set for a physical surgical instrument.

Summary

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Cambridge Endoscopic Devices, Inc. 210K

Cambridge Endoscopic Devices, Inc. 119 Herbert Street Framingham, MA 01702

KO 61425

afety and Effectiveness 510K Summarv May 17, 2006

1. Sponsor Name Cambridge Endoscopic Devices, Inc.
  Page 1 of 2

2. Device Name

Proprietary Name: pureWrist™ electrocautery laparoscopic instruments Common/Usual Name: Electrosurgical cutting and coagulation device and accessories

Identification of Predicate or Legally Marketed Device 3.

The Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments are substantially equivalent to the Ethicon Endo-Surgery, Inc. ENDOPATH® Endoscopic Instruments cleared and under K984240.

4. Device Description

Intended Use રું.

The pureWrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

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510K

Cambridge Endoscopic Devices, Inc. 119 Herbert Street Framingham, MA 01702

K061425

510K Summary of Safety and Effectiveness (Continued) May 17, 2006

Page 2 of ②

6. Comparison of Technological Characteristics

The pureWrist™ electrocautery laparoscopic instruments have the same technological characteristics as the predicate devices. Each of the devices are scissors, graspers, or dissectors that coagulate tissue using monopolar technology. Each use sharp objects to permit the surgeon to cut or dissect tissue. Each of the devices are connected to the same or similar electrosurgical generators and use similar power ranges for operation. The devices have the same intended use, indications for use, technological features including similar design, performance, and material characteristics which further supports the concept of substantial equivalence.

7. Performance Testing

Pre-dinical testing was used to evaluate performance to ensure that the device can be used as designed. The testing evaluated ergonomics of the handle and rotating knob, tissue trauma, grasping and dissecting ability, and electrical insulation requirements. The studies demonstrated acceptable reliability and design performance relative to the predicate device.

8. Statement of Equivalency

Based on the design and intended use, the Cambridge Endoscopic Devices, Inc. pureWrist™ electrocautery laparoscopic instruments are substantially equivalent to the Ethicon Endo-Surgery, Inc. ENDOPATH® instruments cleared under K984240.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2006

Cambridge Endoscopic Devices, Inc. % Mr. Jacob Jacobson Chairman 119 Herbert Street Framingham, Massachusetts 01752

Re: K061425

Trade/Device Name: pureWrist™ Electrocautery Laparoscopic Instrument Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 17, 2006 Received: May 24, 2006

Dear Mr. Jacobson:

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 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.

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Page 2 -- Mr. Jacob Jacobson

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/cdrl/industry/support/index.html.

Sincerely yours,

Hubert Lenoir us

Mark N. Melkerson 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): Not Assigned

K061425

Device Name: pureWrist™ Electrocautery Laparoscopic Instruments

Indications for Use:

The pure Wrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

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)

Hechel Lerner

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number K061425

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.