ASLAN SENSOR MODULAR INSTRUMENT

K982287 · Aslan Medical Technologies, Ltd. · GCJ · Aug 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982287
• Device Name: ASLAN SENSOR MODULAR INSTRUMENT
• Applicant: Aslan Medical Technologies, Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aslan Modular Instruments are intended to be used by a qualified surgeon for grasping, manipulating, cutting and/or coagulating tissue in endoscopic (videoscopic) procedures.

Device Story

Aslan Modular Instruments are re-usable laparoscopic surgical tools consisting of interchangeable shafts, handles, and tips. Designed for use in endoscopic procedures, the device allows surgeons to grasp, manipulate, cut, and cauterize delicate tissues using monopolar electrocautery. The modular design features removable tips and actuating rods, and a tip-and-shaft assembly that detaches from the handle to facilitate cleaning. The instruments are sized for use through 5mm, 10mm, or 12mm cannulae, with lengths ranging from 12cm to 45cm. Operated by a surgeon in a clinical or OR setting, the device provides mechanical and electrical tissue interaction to assist in surgical tasks.

Clinical Evidence

Bench testing only. Evaluations confirmed instruments met requirements for material strength, electrical conductivity, and ease of cleaning/use. Compliance with ANSI/AAMI HF18-1993 for high voltage resistance in electrocautery was verified with no failures.

Technological Characteristics

Modular re-usable laparoscopic instruments; components include shafts, handles, and interchangeable tips. Dimensions: 5mm, 10mm, 12mm diameter; 12cm to 45cm length. Energy source: Monopolar electrocautery. Standards: ANSI/AAMI HF18-1993 for electrical safety. Design allows for disassembly for cleaning.

Indications for Use

Indicated for use by qualified surgeons for grasping, manipulating, cutting, and/or coagulating tissue during endoscopic (videoscopic) procedures.

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.

Predicate Devices

• Circon Snap-In Snap-Out™ Laparoscopic Set
• Karl Storz Take Apart™ Laparoscopic Set

Submission Summary (Full Text)

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### AUG 6 1998

Attachment 8 - 510(k) Summary

K982287

## 510(k) Summary

| | 510(k) Summary | Information supporting claims of substantial equivalence as defined under the<br>Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is<br>summarized below. For the convenience of the Reviewer, this summary is<br>formatted in accordance with the Agency's final rule "... 510(k) Summaries and<br>510(k) Statements..." (21 CFR 807) and can be used to provide a substantial<br>equivalence summary to anyone requesting it from the Agency. | | |
|--|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | | NEW DEVICE NAME: ASLAN LAPAROSCOPIC SET | | |
| | | PREDICATE DEVICE NAMES: Circon Snap-In Snap-Out™ Laparoscopic Set<br>Karl Storz Take Apart™ Laparoscopic Set | | |
| | Device Description | Aslan Modular Instruments comprise a modular line of re-usable instruments<br>consisting of various size shafts, handles of various configurations, and a number of<br>interchangeable tips which can be used in laparoscopic surgery for grasping,<br>cutting, and cauterizing delicate tissues using monopolar electrocautery. The tips<br>and shafts, sized to fit through 5mm, 10mm or 12mm cannulae, range in length<br>from 12cm to 45cm. For ease of cleaning, the tip, together with its actuating rod,<br>can be completely removed from the shaft, and the tip-and-shaft assembly may be<br>completely removed from the handle. | | |
| | Intended Use | Aslan Modular Instruments are intended to be used by a qualified surgeon for<br>grasping, manipulating, cutting and/or coagulating tissue in endoscopic<br>(videoscopic) procedures. | | |
| | Indications Statement | Aslan Modular Instruments are intended to be used by a qualified surgeon for<br>grasping, manipulating, cutting and/or coagulating tissue in endoscopic<br>(videoscopic) procedures. | | |
| | Technological<br>Characteristics | The new laparoscopic set is technologically like the predicate devices. Differences<br>do not raise new questions of safety and effectiveness. | | |
| | Performance Data | Benchtop evaluations were conducted on each of the instruments in the<br>laparoscopic set to ensure that they met or exceeded all requirements for their<br>intended use (strength of materials, electrical conductivity, ease of cleaning, and<br>ease of use). Where specific standards exist (e.g., for resistance to high voltage in<br>electrocautery use: ANSI/AAMI HF18-1993), each instrument in the laparoscopic<br>set passed the tests without a single failure. | | |
| | Conclusions | Based on the information provided herein, we conclude that the new laparoscopic<br>instrument set is substantially equivalent to the Predicate Devices under the Federal<br>Food, Drug and Cosmetic Act. | | |
| | Contact | Thomas J. Hoogeboom, Ph.D.<br>President<br>Aslan Medical Technologies, Ltd.<br>4110 South 9th Street<br>Kalamazoo, Michigan, USA 49009 | | |
| | Date | July 1, 1998 | | |
| | | | | |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

6 1998 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas J. Hoogeboom, Ph.D. President Aslan Medical Technologies, Ltd. 4110 South 9th Street Kalamazoo, Michigan 49009

Re: K982287 Trade Name: Aslan Sensor Modular Instrument Regulatory Class: II Product Code: GCJ Dated: June 26, 1998 Received: June 30, 1998

Dear Dr. Hoogeboom:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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## Page 2 -Thomas J. Hoogeboom, Ph.D

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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 5a - Indications for use 510(k) Premarket Notification Aslan Modular Instrument Aslan Medical Technologies, Ltd.

#### Aslan Sensor™ Modular Instrument Device Name:

Indications for use:

Aslan Sensor™ Modular Instruments are intended to be used by a qualified surgeon for grasping, Asian Sellsof --- Modular Instruments are intended to or association of the scopic) procedures.

# (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 General Restorative Devices | |
| 510(k) Number | K982287 |

| Prescription Use (Per 21 CFR 801.109) | <div style="display:inline-block;">✓</div> |
|---------------------------------------|--------------------------------------------|
|---------------------------------------|--------------------------------------------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)

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