(175 days)
No
The summary describes a mechanical laparoscopic instrument and its connection to a control device, focusing on physical manipulation and movement. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis.
No
The device, HandX, is described as assisting in the control of laparoscopic instruments for tissue manipulation during surgical procedures, which are interventional rather than therapeutic in nature.
No
The device is described as an instrument for endoscopic manipulation of tissue during laparoscopic surgical procedures, specifically a needle holder used for suturing. Its stated purpose is mechanical manipulation, not diagnosis.
No
The device description explicitly states it is a "single-use, disposable, ETO sterilized instrument" and describes its physical connection and mechanical function with the HandX™ device, indicating it is a hardware component, 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 that the device is for "endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures." This describes a surgical instrument used in vivo (within the body) for direct manipulation of tissues.
- Device Description: The description details a "Self-Righting Needle Holder" used with a "HandX™ device" to articulate movement and assist in suturing. This is consistent with a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / 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.
Product codes
GCJ
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.
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
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.
- 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. Conclusion: 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. Conclusion: 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. Conclusion: 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. Conclusion: 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. Conclusion: 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. Conclusion: The subject device demonstrated transition ability of surgical needles to right position, thus met the predefined requirements.
Key Metrics
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 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)
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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.