(54 days)
No
The summary describes a laparoscopic instrument and its electrosurgical electrode, focusing on mechanical articulation and standard electrosurgical function. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an electrosurgical electrode and system used by trained physicians during laparoscopic surgical procedures to manipulate tissue, perform cutting, and coagulation, rather than providing therapy itself.
No
The device is described as assisting in the control of laparoscopic instruments for manipulation of tissue including grasping, approximation, ligation, suturing, cutting and/or coagulation, which are all surgical (therapeutic) interventions, not diagnostic procedures.
No
The device description explicitly details a physical Monopolar Hook, a single-use sterile electrosurgical electrode, which is a hardware component. The summary also mentions bench testing involving physical and mechanical properties of the device.
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 (grasping, cutting, coagulation, etc.). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces its use as a surgical tool (electrosurgical electrode) connected to an electrosurgical unit for applying diathermy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The description and intended use of the HandX and its Monopolar Hook do not involve the analysis of such specimens.
Therefore, the HandX and its Monopolar Hook are surgical instruments, not IVD devices.
N/A
Intended Use / Indications for Use
The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures.
The HandX monopolar instruments are connected by a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
Product codes
GCJ, GEI
Device Description
The Monopolar Hook is a single use sterile electrosurgical electrode for use with the HandX™ device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors' rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
The Monopolar Hook 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
Biocompatibility testing, bench testing and a pre-clinical study were performed to support a determination of substantial equivalence. The results of the tests met acceptance criteria and demonstrated the safety and substantial equivalency of the Monopolar Hook. No safety or performance issues were raised during the testing.
Biocompatibility Testing: The Monopolar Hook is categorized according to ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone. Per the categorization, the following endpoints were considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity.
Electrical Safety and ElectroMagnetic Compatibility (EMC): The Monopolar Hook was found to fully comply with the requirements of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6.
Bench Testing: The Monopolar Hook was subjected to bench testing to evaluate device performance and demonstrate that the design outputs meet the design input requirements and that the device is safe and effective for its intended use. The verification bench testing included:
- Physical / Dimensional Inspection and Tip Measurements
- Functional Test
- Impedance Test
- DC Hipot-Ramp to Failure
- Generator Cable Pull Test
- Seal Test
- Sterile Barrier
- Mechanical Strength – Pull to Failure
- Passivation Verification Corrosion Test
- Shaft's Insulation Integrity Test
All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness.
Animal Study: The Monopolar Hook was tested in a porcine model to evaluate the device's safety, functional performance, and usability. Device safety was assessed by a histopathology evaluation of slits performed by the Monopolar Hook in comparison to those performed by the predicate device (Covidien's, SILS L-Hook (K091869)). The Monopolar Hook performed similarly when compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
HandXTM, Human Xtensions (K173919), SILS L-Hook, Covidien (K091869)
Reference Device(s)
Not Found
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.
0
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February 1, 2021
Human Xtensions Ltd. % Randy Prebula Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K203603
Trade/Device Name: Monopolar Hook Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, GEI Dated: December 9, 2020 Received: December 9, 2020
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
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 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,
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
Indications for Use
510(k) Number (if known) K203603
Device Name Monopolar Hook
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 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) |
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3
Premarket Notification 510(k) Summary – K203603
The Company's 510(k) Summary is provided below.
| 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: | February 1, 2021 |
| Subject Device: | |
| Device Name: | Monopolar Hook |
| Common Name: | Electrosurgical electrode |
| Device Classification Name: | Laparoscope, General & Plastic Surgery |
| Product Codes: | GCJ, GEI |
| Product Class: | Class II |
| Regulation Numbers: | 21 CFR Parts 876.1500, 878.4400 |
| Predicate Devices: | HandXTM, Human Xtensions (K173919)
SILS L-Hook, Covidien (K091869) |
| Device Description: | |
The Monopolar Hook is a single use sterile electrosurgical electrode for use with the HandX™ device. The Monopolar Hook is connected to the HandX device and transmits the HandX device motors' rotation in order to articulate the movement of the end effector of the Monopolar Hook. It is designed to address surgeons' needs relating to the application of monopolar diathermy for various surgical purposes.
The Monopolar Hook is connected to a standard electrosurgical unit via a standard generator cable.
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
4
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.
Contraindications:
The HandX is not intended for contraceptive coagulation of fallopian tissue, but may be used to achieve homeostasis following transaction of the fallopian tube.
Comparison of Technological Characteristics With the Predicate Devices:
The Monopolar Hook is substantially equivalent to the predicate devices, Human Xtensions' HandX (K173919) and Covidien's SILS L-Hook (K091869), in its intended use, contraindications, fundamental technology, sterilization method and general characteristics. The Monopolar Hook's electrosurgical characteristics were compared for usability and safety to the predicate device, the SILS L-Hook (K091869), under animal study. The similarities of the technological characteristics of the Monopolar Hook compared to the predicate devices are further outlined in Table 1, below.
Performance Data:
Biocompatibility testing, bench testing and a pre-clinical study were performed to support a determination of substantial equivalence. The results of the tests met acceptance criteria and demonstrated the safety and substantial equivalency of the Monopolar Hook. No safety or performance issues were raised during the testing.
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing:
The Monopolar Hook is categorized according to ISO 10993-1 as an externally communicating device in limited (≤24 hours) contact with tissue or bone. Per the categorization, the following endpoints were considered: cytotoxicity, sensitization, acute systemic toxicity, and material mediated pyrogenicity.
Electrical Safety and ElectroMagnetic Compatibility (EMC):
The Monopolar Hook was found to fully comply with the requirements of the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18, and IEC 60601-1-6.
Bench Testing:
The Monopolar Hook was subjected to bench testing to evaluate device performance and demonstrate that the design outputs meet the design input requirements and that the device is safe and effective for its intended use.
The verification bench testing included:
- Physical / Dimensional Inspection and Tip Measurements ●
- Functional Test ●
5
Human Xtensions Ltd., Monopolar Hook, K203603
- Impedance Test
- DC Hipot-Ramp to Failure
- Generator Cable Pull Test
- Seal Test
- . Sterile Barrier
- Mechanical Strength – Pull to Failure
- Passivation Verification Corrosion Test ●
- Shaft's Insulation Integrity Test ●
All tests met the predefined acceptance criteria. The testing identified no new questions of safety and effectiveness.
Animal Study:
The Monopolar Hook was tested in a porcine model to evaluate the device's safety, functional performance, and usability. Device safety was assessed by a histopathology evaluation of slits performed by the Monopolar Hook in comparison to those performed by the predicate device (Covidien's, SILS L-Hook (K091869)). The Monopolar Hook performed similarly when compared to the predicate device.
Conclusion:
Based upon the intended use, technological characteristics, safety and performance testing, as well as comparison to the predicate devices, it can be concluded that the Monopolar Hook is substantially equivalent to its predicate devices. The minor differences between the subject and predicate devices do not raise any questions of safety and effectiveness.
6
| Description | Human Xtensions
Monopolar Hook | Human Xtensions
HandX (K173919) | Covidien SILS
L-Hook (K091869) | Substantial
Equivalence |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Product Code | GCJ
GEI | GCJ | GCJ | Same |
| CFR | 876.1500
878.4400 | 876.1500 | 876.1500 | 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 SILS™ L-Hook single use
articulating hook with
monopolar cautery has
application in endoscopic,
gynecological, and general
abdominal and thoracic
laparoscopic procedures.
When connected by a standard
cable to an electrosurgical
power source, the device may
be utilized for monopolar
cautery. | Same |
| Contra-
indications | Not intended for
contraceptive
coagulation of
fallopian tissue, but
may be used to
achieve homeostasis
following transaction
of the fallopian tube. | N/A | Not intended for contraceptive
coagulation of fallopian tissue,
but may be used to achieve
homeostasis following
transaction of the fallopian
tube. | Same |
| Technological Characteristics | | | | |
| Specialty | Laparoscopic | Laparoscopic | Laparoscopic | Same |
| Mode of
operation | Electromechanically
operated, software
controlled | Electromechanically
operated, software
controlled | Manual, hand maneuvered | Same |
| Insertion
Method | Via Trocar | Via Trocar | Via Trocar | Same |
| Articulation | Yes | Yes | Yes | Same |
| Articulation
range | 0 to 85° | 0 to 85° | 0 to 85° | Same |
| Articulation
locking feature | Yes | Yes | Yes | Same |
| Tip axial
rotation feature | 360° | 360° | 360° | Same |
| Shaft material | Stainless steel | Stainless steel | Stainless steel | Same |
| Electrosurgical Characteristics | | | | |
| Application
Technology | Monopolar | N/A | Monopolar | Same |
| Instrument type | Monopolar L-shaped
hook | N/A | Monopolar L-shaped hook | Same |
| Tip length | 5.7 mm to 6.5 mm | N/A | 6.0 mm | Similar |
| Tip width | 4.6 mm | N/A | 4.7 mm | Similar |
| Material for
electrode tip | Stainless steel | N/A | Stainless steel | Same |
| Energy
activation | Generator foot pedal
switch | N/A | Device finger-controlled switch | Both get
energy from
ESU; user
controls the
activation |
| Other Attributes | | | | |
| Sterilization
method | EtO | EtO | EtO | Same |
| Sterility
assurance level | 10-6 | 10-6 | 10-6 | Same |
Table 1 – Substantial Equivalence Table
7