(79 days)
No
The device description and performance studies focus on mechanical and electrical functionality, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is described as an electrocautery laparoscopic instrument for grasping, mobilization, dissection, and transection of tissue, which are surgical tools, not devices primarily intended for therapy.
No
The provided text describes the device as facilitating "grasping, mobilization, dissection, and transection of tissue" and having a "monopolar cautery connector for electrosurgery." These functions are therapeutic or surgical in nature, not diagnostic.
No
The device description clearly outlines physical hardware components (shaft, end effector, handle, connector) and their mechanical and electrical functions, indicating it is a physical 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 the device is for "grasping, mobilization, dissection, and transection of tissue" during minimally invasive surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a surgical instrument with a shaft, end effector (scissors, dissector, or hook), handle, and a cautery connector. These are all components of a surgical tool used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The pureWrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.
Product codes
GEI
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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
-
- Sponsor Name Cambridge Endoscopic Devices, Inc.
Page 1 of 2
- Sponsor Name Cambridge Endoscopic Devices, Inc.
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
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.
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.
1
510K
Cambridge Endoscopic Devices, Inc. 119 Herbert Street Framingham, MA 01702
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.
3
2
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.
3
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
4
Indications for Use
510(k) Number (if known): Not Assigned
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
Page 1 of 1
510(k) Number K061425
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