STONE EXTRACTOR

K971123 · Phx Technologies Corp. · OCZ · Jun 27, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971123
• Device Name: STONE EXTRACTOR
• Applicant: Phx Technologies Corp.
• Product Code: OCZ · Gastroenterology, Urology
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of gallstones.

Device Story

Stone extractor is a manual surgical instrument used during endoscopic surgery to facilitate gallstone removal. Device consists of a 13.0" tube with a 0.6" scoop at the distal end and a nominal diameter of 0.392". Fabricated from 304 stainless steel, the device features a polished proximal section and a matte-finished distal section. Operated by a surgeon during endoscopic procedures, the device is inserted through a cannula to capture and remove stones. The device is reusable and sold non-sterile, requiring sterilization by the user. It is designed to be used in conjunction with a compatible trumpet valve. Proper handling is required during insertion and removal through hinged valves to prevent mechanical damage or snagging.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: 304 stainless steel. Dimensions: 13.0" length, 0.392" diameter, 0.6" scoop. Surface finish: polished proximal, matte distal. Reusable. Sold non-sterile. Mechanical device; no energy source or software.

Indications for Use

Indicated for use during endoscopic surgery for gallstone removal. Contraindicated when physician judgment deems use contrary to patient interest.

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

• American Hydro-Surgical Instruments, Inc. stone extractor (no 510(k) number provided)

Submission Summary (Full Text)

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PHX Technologies Corporation

K971123

Post Office Box 1059, Lewisville, Texas 75067 [phone] FAX [phone]

# 510(K) Summary

Date: 21 March 1997

JUN 27 1997

Trade Name: Stone Extractor

Common Name: Stone Extractor

Classification Name: Unknown

Device Description: The stone extractor has a nominal diameter of 0.392", a tube length of 13.0" and has a scoop 0.6" long. The surface of the stone extractor is polished on the proximal 3.0" and matte finished on the remaining 10.0". The stone extractor is fabricated from 304 stainless steel.

Intended Use: This stone extractor is indicated for use in laproscopic surgery for the removal of gall stones.

Substantial Equivalence: This stone extractor, Submitted Device is, substantially equivalent to the stone extractor, Predicate Device, currently being sold in the United States by American Hydro-Surgical Instruments, Inc., 430 Commerce Drive, Delray, Florida 33445 To the best of our knowledge, this predicate devices is being "legally" marketed.

Comparison to Predicate Device:

| Attribute | Predicate Device | Submitted Device |
| --- | --- | --- |
| Material of construction, Stone extractor | Stainless steel | Stainless steel |
| Material of construction, handle | Aluminum | Stainless steel |
| Stone extractor, nominal diameter, inches | 0.392" | 0.392 |
| Stone extractor, nominal length, inches | 13.0" | 13.0" |
| Stone extractor, nominal length, Scoop, inches | 0.6" | 0.6" |
| Reuseability | Reuseable | Reuseable |
| Sterility | Sold non-sterile | Sold non-sterile |

Submitter's Name: PHX Technologies Corporation

Submitter's Address: 1032 Shady Oaks Drive, No. 100, Denton, TX 76205

Submitter's Phone #: [phone]

Submitter's FAX: [phone]

Submitter's Contact Person: James F. Chapel

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 27 1997

Mr. James F. Chapel
President
PHX Technologies Corporation
P.O. Box 1059
Lewisville, Texas 75067

Re: K971123
Stone Extractor
Dated: May 13, 1997
Received: May 19, 1997
Regulatory class: II
21 CFR §876.1500/Product code: 78 KOG

Dear Mr. Chapel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K971123

Device Name: Billiary Stone Extractor

Indications For Use:

Indications: This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of gallstones.

Contraindications: This instrument is contraindicated for use when, in the judgment of the physician, it's use would be contrary to the best interest of the patient.

Precautions: During surgery this instrument must be handled with care to avoid misuse and possible damage. Use care when passing this instrument through a cannula. When inserting the instrument into a cannula that has a hinged valve, make sure that the valve is fully open. When removing the instrument from a cannula that has a hinged valve, make sure that the valve is fully open and pull the instrument straight out, as lateral or side movement may cause the tip to hang on the valve.


(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, ENT, and Radiological Devices
510(k) Number K971123

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)