(189 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The device description focuses on mechanical and electrical functions.
No
The device is described as an electrosurgical electrode for use with a laparoscopic instrument, facilitating actions like cutting and coagulation during surgery, rather than providing therapy itself.
No
The device is described as an electrosurgical electrode for manipulating tissue (grasping, cutting, coagulation) during surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "single-use sterile electrosurqical electrode" and mentions physical components like motors and an end effector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures for manipulating tissue, cutting, coagulation, etc. This is an in vivo application (within a living organism).
- Device Description: The description reinforces its use as a surgical tool connected to an electrosurgical unit for applying diathermy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples in vitro (in a lab setting) to diagnose or monitor conditions. This device is a surgical instrument used directly on the patient during surgery.
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 HandX™ Monopolar Spatula is a single-use sterile electrosurgical electrode for use with the HandX™ device. The Monopolar Spatula is connected to the HandX™ device and transmits the device motors' rotation to articulate the movement of the end effector of the Monopolar Spatula. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
The Monopolar Spatula is connected to a standard electrosurgical unit via a standard generator cable.
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)
Biocompatibility Testing: The Monopolar Spatula is categorized per ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone. Accordingly, the following endpoints were considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity. The device was deemed to pose a negligible risk of toxicity and is considered to have met the requirements of ISO 10993-1:2018 and FDA's corresponding guidance and to be safe for use as intended.
Electrical Safety and Electromagnetic Compatibility (EMC): The Monopolar Spatula was found to fully comply with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6.
Bench Testing: Bench testing was conducted to evaluate device performance and to 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:
- Verification of Dimensional attributes
- Seal Test
- Tip Pull to Failure
All tests met the predefined acceptance criteria, and testing identified no new questions of safety and effectiveness.
Thermal Effects Testing: Ex-vivo and in-vivo studies were conducted using a porcine model to evaluate the thermal behavior and the lateral thermal spread of the Monopolar Spatula compared to its predicate and reference devices. The results supported the substantially equivalent thermal behavior of the Monopolar Spatula compared to the predicate and reference devices.
Human Factors/Usability: A summative evaluation study (per IEC 62366-1) confirmed that the device can be used safely and effectively in accordance with its labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Monopolar Hook, Human Xtensions (K203603)
Reference Device(s)
ENDOPATH Electrosurgery PROBE PLUS II (K160128)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2023
Human Xtensions Ltd. % Randy Prebula Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K222011
Trade/Device Name: HandX Instrument - Monopolar Spatula Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GEI Dated: December 14, 2022 Received: December 14, 2022
Dear Randy Prebula:
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,
Colin K. Chen -S
for
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 Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name HandX™ Monopolar Spatula
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.
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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:
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3
510(k) SUMMARY
Human Xtensions Ltd.'s HandX
| Submitter: | Human Xtensions Ltd.
4 Meir Ariel Street
Grand Netter Building
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: | January 11, 2023 |
| Subject Device: | |
| Device Name:
Common Name: | HandX™ Monopolar Spatula
Electrosurgical electrode |
| Classification Name:
Product Codes: | Laparoscope, General & Plastic Surgery
GCJ, GEI |
| Product Class:
Regulation Number: | Class II
21 CFR Part 876.1500
21 CFR Part 878.4400 |
| Predicate Device:
Reference Device: | Monopolar Hook, Human Xtensions (K203603)
ENDOPATH Electrosurgery PROBE PLUS II
(K160128) |
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.
4
Device Description
The HandX™ Monopolar Spatula is a single-use sterile electrosurqical electrode for use with the HandX™ device. The Monopolar Spatula is connected to the HandX™ device and transmits the device motors' rotation to articulate the movement of the end effector of the Monopolar Spatula. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
The Monopolar Spatula is connected to a standard electrosurgical unit via a standard generator cable.
Comparison of Technological Characteristics With Predicate Device:
The Monopolar Spatula is substantially equivalent to the predicate device, Human Xtensons' HandX™ Monopolar Hook (K203603), in its intended use, contraindications, fundamental technology, mechanical performance characteristics and sterilization method. The Monopolar Spatula is an alternative electrode for the Monopolar Hook for surgical tasks that require monopolar cutting and/or coagulation during surgeries. It differs from the Monopolar Hook only in the end effector's tip shape and material; all other components and assembly configuration are identical.
The electrical functionality of the Monopolar Spatula is equivalent to that of the cleared Monopolar Hook. The MonopolarSpatula's usability and safety aspects were compared to the predicate device in Human Factors Summative Evaluation, bench tests, and in vivo testing,
Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing:
The Monopolar Spatula is categorized per ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone. Accordingly, the following endpoints were considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity. The device was deemed to pose a negligible risk of toxicity and is considered to have met the requirements of ISO 10993-1:2018 and FDA's corresponding guidance and to be safe for use as intended.
Electrical Safety and Electromagnetic Compatibility (EMC):
The Monopolar Spatula was found to fully comply with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-6.
Bench Testing:
Bench testing was conducted to evaluate device performance and to 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:
- · Verification of Dimensional attributes
- · Seal Test
- Tip Pull to Failure
All tests met the predefined acceptance criteria, and testing identified no new questions of safety and effectiveness.
Thermal Effects Testing:
Ex-vivo and in-vivo studies were conducted using a porcine model to evaluate the thermal behavior and the lateral thermal spread of the Monopolar Spatula compared to its predicate and reference
5
devices. The results supported the substantially equivalent thermal behavior of the Monopolar Spatula compared to the predicate and reference devices.
Human Factors/Usability:
A summative evaluation study (per IEC 62366-1) confirmed that the device can be used safely and effectively in accordance with its labeling.
Conclusion
Based upon the intended use, technological characteristics, safety and performance testing, as well as comparison to the predicate device, it can be concluded that the HandX™ Monopolar Spatula is substantially equivalent to its predicate device. The minor differences between the subject and predicate device do not raise any different questions of safety and effectiveness, and the design controls and data collected ensure no adverse impact on safety or effectiveness.