(60 days)
Not Found
No
The summary describes an electromechanically controlled laparoscopic device that translates the surgeon's hand movements directly to the instrument tip. There is no mention of AI or ML in the intended use, device description, or performance studies. The control mechanism is described as a direct translation of surgeon input, not an intelligent or learning system.
No
The device is a surgical tool used to perform actions like grasping, cutting, and suturing, which are part of surgical procedures rather than therapeutic treatment of a condition.
No
The device is described as assisting in the control of laparoscopic instruments for manipulation of tissue during surgical procedures. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states that the HandX device is electromechanically controlled and includes both hardware and software, and describes physical components like the Handpiece and Instrument.
Based on the provided text, the HandX device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used during laparoscopic surgical procedures for manipulating tissue (grasping, cutting, suturing, etc.). This is a direct surgical intervention on the patient's body.
- Device Description: The description details a handheld powered laparoscopic device with instruments for surgical tasks. It acts as a "surgeon's hand extension."
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The HandX does not perform any such analysis of biological samples.
The HandX is a surgical instrument used on the patient, not a device used to test samples from the patient.
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 (comma separated list FDA assigned to the subject device)
GCJ, NAY, GEI
Device Description
The Human Xtensions HandX is a handheld powered laparoscopic device. The HandX enables, by its attached instruments Grasper, Needle Holder and Monopolar Hook, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension," enhancing maneuverability and control.
The HandX device is electromechanically controlled and includes both hardware and software. The device is comprised of two main parts: the Handpiece and the Instrument. The Handpiece consists of a reusable Control Interface (CI) handle and Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip. The tip moves according to the CI's direction. Before use, a set of Power Cable, Finger Pads, Arc and Spacer are assembled on the Handpiece and the Handpiece is covered with a standard sterile cover (not provided with the HandX device). After use, the Instrument is disposed of, and the Handpiece is cleaned and disinfected per specifications in the Instructions for 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
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)
The company conducted usability testing of the inverted control mode in line with IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, as well as FDA's 2016 guidance document. The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users.
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
§ 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.
0
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September 13, 2021
Human Xtensions Ltd. % Randy Prebula Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K212214
Trade/Device Name: HandX Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, NAY, GEI Dated: July 15, 2021 Received: July 15, 2021
Dear Randy Prebula:
We have reviewed vour 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
1
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): 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 (QS) 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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
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 on last page
510(k) Number (if known) K212214
Device Name
HandX
Indications for Use (Describe)
The HandX is intended to assist in the control of Human Xtensions 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)
Z Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
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FORM FDA 3881 (6/20)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 ER
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510(k) SUMMARY
Human Xtensions Ltd.'s HandX
| Submitter: | Human Xtensions Ltd.
4 Meir Ariel Street
Netanya, 4250574, Israel
Telephone: + (972) 77 36 30 300 |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Randy J Prebula
Hogan Lovells US LLP
Columbia Square
555 Thirteenth Street, NW
Washington, DC 20004
Telephone: +1 202 637 5600
Direct: +1 202 637 6548
Fax: +1 202 637 5910
Email: randy.prebula@hoganlovells.com |
| Date Prepared: | September 9, 2021 |
| Subject Device: | |
| Device Name:
Common Name:
Classification Name:
Product Codes:
Product Class:
Regulation Number: | HandX
HandX
Laparoscope, General & Plastic Surgery
GCJ, NAY, GEI
Class II
21 CFR 876.1500, 876.4400 |
| Predicate Devices: | HX Device, Human Xtensions (K173919)
Monopolar Hook, Human Xtensions (K203603) |
Purpose of the Special 510(k) Notice
The HandX is a modification to the prior versions of the device that were cleared under K173919 (HX Device) and K203603 (Monopolar Hook).
Intended 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.
Device Description
The Human Xtensions HandX is a handheld powered laparoscopic device. The HandX enables, by its attached instruments Grasper, Needle Holder and Monopolar Hook, the surgeon to perform a variety
4
of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension," enhancing maneuverability and control.
The HandX device is electromechanically controlled and includes both hardware and software. The device is comprised of two main parts: the Handpiece and the Instrument. The Handpiece consists of a reusable Control Interface (CI) handle and Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip. The tip moves according to the CI's direction. Prior to use, a set of Power Cable, Finger Pads, Arc and Spacer are assembled on the Handpiece and the Handpiece is covered with a standard sterile cover (not provided with the HandX device). After use, the Instrument is disposed of, and the Handpiece is cleaned and disinfected per specifications in the Instructions for Use.
The HandX has nearly identical technological characteristics and principles of operation as the combined predicate devices. The only notable difference between the subject HandX and the combined predicates is the addition of the inverted control mode; whereas the predicate devices' software included only direct control ("Ro-bo style") for the Cl. the subject HandX provides direct control as well as inverted control ("La-pro style") as an additional, optional CI control mode. This difference does not raise new questions of safety or effectiveness, as it does not alter the fundamental therapeutic purpose of the device or its basic principles of operation (users control the inserted instruments in the same manner, just using one or another set of vectors). The new mode also does not change the key metrics for evaluating device safety and performance, and is supported by successful usability testing (as noted below).
Performance Data
The company conducted usability testing of the inverted control mode in line with IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, as well as FDA's 2016 guidance document. The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users.
Conclusion
Based on the intended use, technological characteristics, principles of operation, and usability testing, it can be concluded that the HandX is substantially equivalent to its predicate devices.
5
Substantial Equivalence (SE) Table
| | Human Xtensions HandX (Modified
Device) | Human Extensions HX Device
(K173919) | Human Xtensions Monopolar Hook
(K203603) | Comparison of
Subject to Predicates |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use in various laparoscopic
surgeries to perform a variety of surgical
functions, including grasping,
approximation, ligation, suturing, cutting
and/or coagulation | Intended for use in various
laparoscopic surgeries to perform a
variety of surgical functions,
including grasping, approximation,
ligation, and suturing. | Intended for use in various laparoscopic
surgeries to perform a variety of surgical
functions, including grasping,
approximation, ligation, suturing, cutting
and/or coagulation | Same |
| 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. | The HX Device is intended to assist
in the accurate control of HX
laparoscopic instruments including
needle holder and grasper, for
endoscopic manipulation of tissue,
including grasping, approximation,
ligation, suturing, during
laparoscopic surgical procedures. It
is intended to be used by trained
physicians in an operating room
environment in accordance with its
Instructions 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. | Same - Identical to
K203603; only adds
Monopolar Hook to
indications cleared in
K173919 |
| Specialty | Laparoscopic | | | Same |
| Mode of Operation | Electromechanically operated, software controlled | | | Same |
| Components | Handpiece and compatible instruments
(Grasper, Needle Holder, Monopolar
Hook); Arc, Pads, Spacer, Power Cable | Handpiece and compatible
instruments (Grasper, Needle
Holder); Arc, Pads, Spacer, Power
Cable | Instrument compatible with HandX
Handpiece (Monopolar Hook) | Same as combined
predicates |
| Grasper Type | Fenestrated | | N/A* | Same as K173919 |
| Needle Holder Type | Straight - Single Action | | N/A* | Same as K173919 |
| Electrosurgical
Instrument Type | Monopolar hook | N/A | Monopolar hook | Same as K203603 |
| Articulation | Yes | Yes | Yes | Same |
| Control Interface
Mode | Direct control and inverted control | Direct control | N/A* | Adds inverted control
mode |
| Single Use /
Reusable | Handpiece: reusable
Instruments: single use | Handpiece: reusable
Instruments: single use | Instrument: single use | Same as combined
predicates |
| Sterile Components | Instruments, Arc, Finger Pads, Spacer,
and Power Cable | Instruments, Arc, Finger Pads,
Spacer and Power Cable | Instrument (does not include other
components) | Same as K173919 |
*The K203603 filing only included the Monopolar Hook and did not re-include the entire system.