(76 days)
No
The summary describes a mechanical surgical instrument and its connection to a control device, focusing on its physical function and safety testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as assisting in the control of laparoscopic instruments for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting, and/or coagulation during surgical procedures. These actions constitute a direct medical benefit, thus classifying it as a therapeutic device.
No
The HandX™ is described as an instrument intended to assist in the control of laparoscopic instruments for endoscopic manipulation of tissue during surgical procedures. Its functions include grasping, approximation, ligation, suturing, cutting, and/or coagulation. These are interventional surgical actions, not diagnostic ones.
No
The device description explicitly mentions "The Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device." and "transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector." This indicates a physical, hardware component that performs a surgical action, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the HandX™ and its instruments are for endoscopic manipulation of tissue during laparoscopic surgical procedures. This involves physical interaction with the patient's body for surgical purposes (grasping, cutting, coagulation, etc.).
- Device Description: The description reinforces that it's a surgical instrument used with a robotic system to perform surgical tasks.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are specifically designed for this purpose.
In summary, the HandX™ and its associated instruments are surgical devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The HandX™ is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX™ monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
Product codes
GCJ, GEI
Device Description
The Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Monopolar Scissors is connected to the HandX and transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
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
trained physicians in an operating room environment
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)
Bench testing, biocompatibility, electrical safety, human factors, and usability evaluations were performed to support a substantial equivalence determination. The results of the tests met the acceptance criteria and demonstrated the safety and substantial equivalency of the Monopolar Scissors. No safety or performance issues were raised during the testing.
Biocompatibility Testing: The Monopolar Scissors is categorized according to ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone. A full biological risk assessment was performed. Based on the biological risk assessment and testing, the device is considered biocompatible.
Electrical Safety and ElectroMagnetic Compatibility (EMC): The Monopolar Scissors was found to fully comply with the requirements of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6.
Bench Testing: The Monopolar Scissors was subjected to bench testing including: Instrument Dimensional Attribute, Articulation Angle and Roll Range Measurement, Roll and Grasp Torque Measurement Method, Instrument Articulation latency, Impedance Test, Dielectric Strength, Insulation Integrity test, Generator Cable Compatibility with Extension Cables, Proximal Seal Test, Tip Integrity, Deflection Integrity, Cutting Integrity, Performance Test (instrument integrity following simulated use), Human Factors Summative Evaluation, Human Factors Labeling Validation, Instrument Corrosion Test. All tests met the predefined acceptance criteria.
Performance Testing - Animal: The HandX Monopolar Scissors was tested in a swine model to evaluate the device's safety, functional performance and usability. The evaluation was executed by performing various surgical tasks, using both the subject device and the reference device. Device safety was assessed by thermal damage evaluation using temperature probes and histopathology evaluation. The Monopolar Scissors instrument passed all the predefined acceptance criteria for safety, performance and usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2023
Human Xtensions Ltd. Hani Rauch RA Manager Meir Ariel 4 Netanya, 4250574 Israel
Re: K230491
Trade/Device Name: HandXTM Monopolar Scissors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, GEI Dated: February 5, 2023 Received: February 23, 2023
Dear Hani Rauch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2013.05.10
08:22:23 -04'00'
Mark Trumbore Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name HandX(TM) Monopolar Scissors
Indications for Use (Describe)
The HandX™ is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX™ monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Premarket Notification 510(k) Summary
The Company's 510(k) Summary is provided below.
| Submitter: | Human Xtensions Ltd.
Grand Netter Building
4 Meir Ariel Street
Netanya, 4250574,
Israel
Telephone: + (972) 77 36 30 300 |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Hani Rauch
Human
Xtensions Ltd.
4 Meir Ariel Street
Netanya, 4250574,
Israel
Telephone: + (972) 77 36 30 300 Email:
hani@human-x.com |
| Date Prepared: | May 7, 2023 |
| Subject Device: | |
| Device Name:
Device Classification Name:
Product Codes:
Product Class:
Regulation Numbers: | HandX™ Monopolar Scissors
Laparoscope, General & Plastic Surgery
GCJ, GEI
Class II
21 CFR Parts 876.1500, 878.4400 |
| Predicate Devices: | Monopolar Hook, Human Xtensions Ltd.
(K203603) |
| Reference device: | ENDOPATH® Scissors, curved, with
monopolar cautery, 5MM (K984240),
Ethicon. |
Device Description:
The Monopolar Scissors is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Monopolar Scissors is connected to the HandX and transmits the motors' rotations to articulate the movement of the Monopolar Scissors' end effector. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
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Indications for Use:
The HandX™ is intended to assist in the control of Human Xtensions laparoscopic instruments, including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX™ monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
Comparison of Technological Characteristics With the Predicate Devices:
The Monopolar Scissors is substantially equivalent to the predicate device. Human Xtensions' Monopolar Hook (K203603), in its intended use, contraindications, fundamental technology, packaging, sterilization method and general characteristics.
The main design characteristics of the instrument's effective length, diameter, materials and compatibility with commonly used 5mm trocars are similar to those of the Monopolar Hook.
The electrosurgical characteristics of the Monopolar Scissors are similar to its predicate device and similarly is connected to a standard Electrosurgical Unit (ESU) via a standard generator cable, which are generic Operating Room (OR) equipment.
Its dissection/cutting of organ/tissue function is comparable with the reference device Ethicon's ENDOPATH® 5MM Curved Scissors with Monopolar Cautery (K984240).
It can be concluded that the Monopolar Scissors is substantially equivalent to its predicate. No new questions of safety and effectiveness were raised.
Performance Data:
Bench testing, biocompatibility, electrical safety, human factors, and usability evaluations were performed to support a substantial equivalence determination. The results of the tests met the acceptance criteria and demonstrated the safety and substantial equivalency of the Monopolar Scissors. No safety or performance issues were raised during the testing.
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing:
The Monopolar Scissors is categorized according to ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone.
The materials of the Monopolar Scissors are similar to those of the previously cleared HandXTM instruments.
A full biological risk assessment for the Monopolar Scissors was performed according to the requirements of ISO 10993-1:2018, ISO 14971:2019 and FDA's guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Per the categorization, the following endpoints were considered: cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
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Based upon the biological risk assessment and the results of biocompatibility testing performed on the device, it can be concluded that the device can be considered biocompatible for use as intended.
Electrical Safety and ElectroMagnetic Compatibility (EMC):
The Monopolar Scissors was found to fully comply with the requirements of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6.
Bench Testing:
The Monopolar Scissors was subjected to bench testing to evaluate its performance and demonstrate that the design outputs meet the design input requirements and that the device is safe and effective for its intended use.
The verification bench testing included the following:
- Instrument Dimensional Attribute
- Articulation Angle and Roll Range Measurement
- Roll and Grasp Torque Measurement Method ●
- Instrument Articulation latency ●
- Impedance Test
- Dielectric Strength ●
- Insulation Integrity test
- Generator Cable Compatibility with Extension Cables
- Proximal Seal Test
- Tip Integrity
- Deflection Integrity
- Cutting Integrity ●
- Performance Test (instrument integrity following simulated use) ●
- Human Factors Summative Evaluation
- Human Factors Labeling Validation ●
- Instrument Corrosion Test ●
All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness.
Performance Testing - Animal
The HandX Monopolar Scissors was tested in a swine model to evaluate the device's safety, functional performance and usability. The evaluation was executed by performing various surgical tasks, using both the subject device and the reference device, by qualified personnel with appropriate experience, followed by questionnaires filled out by the participants.
The device's safety was assessed by thermal damage evaluation using temperature probes and histopathology evaluation according to FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff. Temperature and histopathology evaluations were performed following slits formation on porcine tissue. Slits were performed by the Monopolar Scissors as compared to the reference device ENDOPATH® Scissors (curved, with monopolar cautery, 5MM) in various working modes (pure cut, blend cut, spray and coagulation) and in different energy levels.
It can be concluded that the Monopolar Scissors instrument passed all the per-defined acceptance criteria for safety, performance and usability.
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Conclusion:
Based upon the intended use, indications, technological characteristics and performance testing, it can be concluded that the Monopolar Scissors is substantially equivalent to its predicate device. The differences between the subject and predicate devices do not raise any questions about safety and effectiveness.