← Product Code [GCJ](/productcode/GCJ) · K223718 # HandX™ Self-Righting Needle Holder (K223718) _Human Xtensions , Ltd. · GCJ · Jun 5, 2023 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K223718 ## Device Facts - **Applicant:** Human Xtensions , Ltd. - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Jun 5, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The HandX™ is intended to assist in the control of Human Xtensions 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. ## Device Story HandX™ Self-Righting Needle Holder is a single-use, disposable, ETO-sterilized laparoscopic instrument; connects to HandX™ electromechanical system. System translates motor rotations into end-effector articulation; specifically orients suturing needles to 90° vertical position. Used in operating rooms by trained physicians; assists in tissue manipulation and suturing. Surgeon controls device via HandX™ interface; output is mechanical articulation of the needle holder tip. Benefits include improved needle positioning and control during minimally invasive suturing tasks. ## Clinical Evidence Bench testing only. Testing included articulation angle measurement, dimensional verification, suture holding force, needle pulling moment, needle holding force, and needle righting transition ability. All tests met predefined acceptance criteria. ## Technological Characteristics Stainless steel shaft and electrode tip; 330mm length; 5.5mm diameter. Electromechanically operated via HandX™ system; software-controlled. Features 360° axial rotation and 0-80° articulation. Single-use; ETO sterilized (SAL 10^-6). ## Regulatory 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. ## Special Controls *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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - HX Device, Needle Holder, Human Xtensions Ltd. ([K173919](/device/K173919.md)) ## Reference Devices - ENDOPATH® Self-Righting Needle Holder ([K972679](/device/K972679.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 5, 2023 Human Xtensions Ltd. Orit Yaniv VP QA/RA Human Xtensions Ltd. Grand Netter Building 4 Meir Ariel Street Netanya, 4250574, Israel Telephone: + (972) 77 36 30 300 Email: orit@human-x.com Re: K223718 Trade/Device Name: HandXTM Self-Righting Needle Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 11, 2022 Received: December 12, 2022 Dear Orit Yaniv: 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. {1}------------------------------------------------ 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); 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 medical devices and radiation-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, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.06.05 11:23:01 -04'00' Mark Trumbore, Ph.D. 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) Device Name HandX(TM) Self-Righting Needle Holder Indications for Use (Describe) The HandX is intended to assist in the control of Human Xtensions 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. 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ #### Premarket Notification 510(k) Summary | Submitter: | Human Xtensions Ltd.
Grand Netter Building
4 Meir Ariel Street
Netanya, 4250574, Israel
Telephone: + (972) 77 36 30 300 | |------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Orit Yaniv
Human Xtensions Ltd.
Grand Netter Building
4 Meir Ariel Street
Netanya, 4250574, Israel
Telephone: + (972) 77 36 30 300
Email: orit@human-x.com | | Date Prepared: | May 24, 2023 | | Subject Device: | | | Trade/Device Name:
Common/Usual Name:
Device Classification Name:
Product Codes:
Product Class:
Regulation Numbers: | HandX™ Self-Righting Needle Holder
Articulated Laparoscopic Instruments
Endoscope and Accessories
GCJ
Class II
21 CFR Parts 876.1500 | | Predicate Devices: | HX Device, Needle Holder, Human Xtensions Ltd.
(K173919) | | Reference Device: | ENDOPATH® Self-Righting Needle Holder (K972679)
Ethicon. Used as a reference device for Self-Righting
function. | #### Device Description: The Self-Righting Needle Holder is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Self-Righting Needle Holder is connected to the HandX™ and transmits the motors' rotations to articulate the movement of the Self-Righting Needle Holder's end effector. Self-Righting Needle Holder orients the suturing needle vertically to 90° mounting. It is designed to address the surgeons' needs relating to suturing for various surgical purposes. Indications for Use: {4}------------------------------------------------ The HandX™ is intended to assist in the control of Human Xtensions 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. # Comparison of Technological Characteristics with the Predicate Devices: The Self-Righting Needle Holder is substantially equivalent to the predicate device, Human Xtensions' HX Device (K173919), in its intended use, contraindications, fundamental technology, packaging, sterilization method and general characteristics. Its Self-Righting function is the same as Ethicon's ENDOPATH® Self-Righting Needle Holder (K972679). A summary of the technological characteristics of the Self-Righting Needle Holder device in comparison to those of the predicate device and reference device is presented in the table below. | Description | HandX™ Self-Righting Needle
Holder
(Subject device) | HX Device, Needle Holder
(Predicate device) | ENDOPATH® Self-
Righting Needle
Holder
(Reference device) | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K223718 | K173919 | K972679 | | Product Code | GCJ | GCJ | GAT | | CFR | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.4730 | | Indications for Use | The HandX™ is intended to assist in the control of Human Xtensions 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 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 ENDOPATH® Endoscopic Tissue Fastening System (ETFS) is intended for use in minimally invasive surgical applications where soft tissue is being approximated with the interrupted stitches. | | Contra- indications | This device is intended for use only as indicated. | This device is intended for use only as indicated. | NA | | Specialty | Laparoscopic | Laparoscopic | Minimally invasive surgical application | | Mode of operation | Electromechanically operated, software controlled | Electromechanically operated, software controlled | Manually | | Insertion Method | Via 5mm Trocar | Via 5mm Trocar | Via 5mm Trocar | | Articulation | Yes | Yes | No | {5}------------------------------------------------ | Description | HandX™ Self-Righting Needle
Holder
(Subject device) | HX Device, Needle Holder
(Predicate device) | ENDOPATH® Self-
Righting Needle
Holder
(Reference device) | |---------------------------------|-----------------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------| | Articulation
range | 0 to 80°±10° | 0 to 85°±5° | NA | | Articulation
locking feature | Yes | Yes | NA | | Tip axial
rotation feature | 360° | 360° | NA | | Shaft material | Stainless steel | Stainless steel | Stainless steel | | Instrument type | Self-Righting Needle Holder | Needle Holder | Self-Righting Needle
Holder | | Material for
electrode tip | Stainless steel | Stainless steel | Stainless steel | | Shaft length | 330 mm ±0.1 mm | 330 mm ±0.1 mm | NA | | Shaft diameter | 5.5 mm ±0.2 mm | 5.5 mm ±0.1 mm | NA | | Single Use /
Reusable | Single use instrument | Single use instrument | Re-usable | | Packaging | Blister | Blister | NA | | Provided
sterilized | Yes | Yes | NA | | Sterilization
method | EtO | EtO | NA | | Sterility
assurance level | 10-6 | 10-6 | NA | lt can be concluded that the Self-Righting Needle Holder is substantially equivalent to its predicate. No new questions of safety and effectiveness were raised. # Performance Data: The following performance data were provided in support of the substantial equivalence determination: #### Biocompatibility Testing: The materials of the Self-Righting Needle Holder are identical to those of the predicate device. The predicate device has been tested and is considered biocompatible for its intended use. Therefore, from a biocompatibility and toxicological perspective, the device remains unchanged, and no additional {6}------------------------------------------------ testing is required for the HandX™ Self-righting Needle Holder device since only the jaws geometry of the needle was changed. # Bench Testing: The Self-Righting Needle Holder 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 is described in the table below, all tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness. | Test | Test Summary | Conclusions | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Self-Righting Needle Holder
Angle Test | The purpose of the test was
to measure the subject
device articulation angles
while connected to the
HandX device. | The subject device tip
articulation ability is
comparable to the predicate
device. | | SRNH instrument
Dimensional Attribute | The purpose of the test was
to confirm the subject
device dimensions to the
specifications | The subject device
dimensions are within the
defined requirements. | | SRNH Suture Holding Force | The purpose of the test was
to measure the subject
device suture holding force. | The subject device suture
holding force withstands the
defined requirements as the
predicate device. | | SRNH Needle Pulling
Moment | The purpose of this test was
to determine whether the
subject device maintains
the needle in place under
external moment. | The subject device complies
with the needle pulling
moment requirement. | | SRNH Needle Holding Force | The purpose of this test was
to determine whether the
subject device maintains
the needle in place under
external force. | The subject device complies
with the needle holder
holding force requirement | | SRNH Needle Righting | The purpose of the test was
to verify the subject device
transition ability of a
surgical needle to a right
position. | The subject device
demonstrated transition
ability of surgical needles to
right position, thus met the
predefined requirements. | # Conclusion: Based upon the intended use, indications, technological characteristics and performance testing, as well as comparison to the predicate device, it can be concluded that the Self-Righting Needle Holder is substantially equivalent to its predicate device. The minor differences between the subject and predicate devices do not raise any questions of safety and effectiveness. --- **Source:** [https://fda-staging.innolitics.com/device/K223718](https://fda-staging.innolitics.com/device/K223718) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com