HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM

K051276 · Richard Wolf Medical Instruments Corp. · OCZ · Oct 28, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051276
• Device Name: HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: OCZ · Gastroenterology, Urology
• Decision Date: Oct 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Rigid forceps, scissors and punches serve for endoscopically controlled grasping, manipulating or cutting, and dissection and removal of tissue / organs or foreign bodies and stones through natural or surgically created passages. For investigation, diagnosis and/or therapy with endoscopic accessories in different areas, e.g. surgery, urology and gynecology, performed by adequately trained and qualified medical personnel. Holding and grasping forceps: For removing residual tissue and foreign bodies, for holding tissue and organs, for stone extraction, and for positioning and removing stents. Spoon and biopsy forceps: For removing and gripping tissue and tissue samples, and for extracting foreign bodies. Punch: For removing and separating soft tissue, cartilage, and other non-bony tissue, and for removing tissue. Scissors: For cutting adhesions, for dissecting, exposing and for separating soft tissue.

Device Story

HySafe Micro Modular Forceps, Punches and Scissors System consists of a handle and interchangeable jaw attachments. Device used endoscopically by trained medical personnel in surgery, urology, and gynecology. Operates via manual mechanical actuation to grasp, manipulate, cut, or remove tissue/foreign bodies. Features axial flushing capability for cleaning and an overload protection mechanism in the handle to absorb excessive force, preventing damage and extending service life. Output is the physical manipulation or removal of target tissue/objects. Benefits include improved instrument durability and enhanced cleaning/sterilization access.

Clinical Evidence

No clinical tests performed. Evidence is based on bench testing, specifically strength and aging tests conducted on forceps with strain relief (spring) to ensure no breakage of jaws or components under normal use conditions.

Technological Characteristics

Modular endoscopic instrument system comprising a handle and various jaw attachments. Features include axial flushing for internal cleaning and an integrated overload protection spring in the handle to absorb excessive force. Mechanical actuation. No electronic components or software.

Indications for Use

Indicated for patients requiring endoscopic grasping, manipulation, cutting, dissection, or removal of tissue, organs, foreign bodies, or stones via natural or surgically created passages. Used in surgery, urology, and gynecology by trained medical personnel.

Regulatory Classification

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

• Auxiliary Rigid Forceps (K971315)
• Modular Forceps and Scissors (K935270)

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

Richard Wolf Medical Instruments Corp.
Mr. Robert L. Casarsa
Quality Assurance Manager
353 Corporate Woods Parkway
Vernon Hills, IL 60061-3110

JUL 27 2015

Re: K051276
Trade/Device Name: HySafe Micro Modular Forceps, Punches and Scissors System
Regulation Number: 21 CFR 876.1075
Regulation Name: Gastroenterology-urology biopsy instrument
Regulatory Class: II
Product Code: FCF, FCI, OCZ
Dated (Date on orig SE ltr): October 4, 2005
Received (Date on orig SE ltr): October 6, 2005

Dear Mr. Casarsa,

This letter corrects our substantially equivalent letter of October 28, 2005.

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. 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

{1}

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D.
Director
Division of Reproductive, Gastro-Renal, and Urological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{2}

K051276

# 5.0 Indications for Use

510(k) Number (if known): K051276

Device Name: HySafe Micro Modular Forceps, Punches and Scissors System

Indications For Use: Rigid forceps, punches and scissors serve for endoscopically controlled grasping, manipulating or cutting, and dissection and removal of tissue / organs or foreign bodies and stones through natural or surgically created passages. For investigation, diagnosis and/or therapy with endoscopic accessories in different areas, e.g. surgery, urology and gynecology, performed by adequately trained and qualified medical personnel.

**Holding and grasping forceps**: For removing residual tissue and foreign bodies, for holding tissue and organs, for stone extraction, and for positioning and removing stents.

**Spoon and biopsy forceps**: For removing and gripping tissue and tissue samples, and for extracting foreign bodies.

**Punch**: For removing and separating soft tissue, cartilage, and other non-bony tissue, and for removing tissue.

**Scissors**: For cutting adhesions, for dissecting, exposing and for separating soft tissue.

Prescription Use ☑
AND/OR
Over-The Counter Use

(Part 21CFR 801 Subpart D)
(Part 21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K051276

REVISED 9/27/05
Page 1 of 1

{3}

OCT 28 2005
K051276
Page 1 of 2

RICHARD WOLF
Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, IL 60061-3110
Phone: [phone]
Customer Service: 800-323-WOLF (9653)
www.richardwolfusa.com

| 12.0 510(k) Summary of Safety and Effectiveness | | | | |
| --- | --- | --- | --- | --- |
| Submitter: | | | Date of Preparation: May 16, 2005 | |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | |
| Division name (if applicable): N.A. | | | Phone number (include area code): [phone] | |
| Street address: 353 Corporate Woods Parkway | | | FAX number (include area code): [phone] | |
| City: Vernon Hills | State/Province: Illinois | Country: USA | | ZIP / Postal Code: IL 60061 |
| Contact name: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: | | Model number: | | |
| Common name: | | Classification name: | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 K971315 | 1 Auxiliary Rigid Forceps | | 1 Richard Wolf | |
| 2 K935270 | 2 Modular Forceps and Scissors | | 2 Richard Wolf | |

## 1.0 Description

HySafe Micro Modular Forceps, Punches and Scissors System, consist of a handle and jaw attachment (jaw assembly, various styles/shaped jaws).

## 2.0 Intended Use

Rigid forceps, scissors and punches serve for endoscopically controlled grasping, manipulating or cutting, and dissection and removal of tissue / organs or foreign bodies and stones through natural or surgically created passages.

For investigation, diagnosis and/or therapy with endoscopic accessories in different areas, e.g. surgery, urology and gynecology, performed by adequately trained and qualified medical personnel.

REVISED 10/04/05
12-1

{4}

RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION
K651276
Page 2 of 2

Holding and grasping forceps: For removing residual tissue and foreign bodies, for holding tissue and organs, for stone extraction, and for positioning and removing stents.

Spoon and biopsy forceps: For removing and gripping tissue and tissue samples, and for extracting foreign bodies.

Punch: For removing and separating soft tissue, cartilage, and other non-bony tissue, and for removing tissue.

Scissors: For cutting adhesions, for dissecting, exposing and for separating soft tissue.

### 3.0 Technological Characteristics

The possibility of axial flushing of the insert allows optimal rinsing/cleaning inside. Due to the overload protection in the handle, the service life is significantly increased and reduces the risk of damage during operation by absorbing excessive force.

### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety and effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf.

### 5.0 Performance Data

No performance standards are known.

Strength test and ageing measures on forceps with strain relief (spring) show that there is no breakage of the jaw or other parts of the instrument if used normally.

### 6.0 Clinical Tests

No clinical tests performed.

### 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.

By:
Robert L. Casarsa
Quality Assurance Manager
Date: Oct 4, 2005

REVISED 10/04/05
12-2