AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM

K982623 · Aesculap, Inc. · GCJ · Sep 30, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982623
• Device Name: AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Aesculap Needlescopic Instrument System (N.I.S.) is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.

Device Story

System comprises 2.5mm trocar, 2.0mm endoscope, and 2.5mm modular instruments. Trocar establishes access ports for abdominal cavity; endoscope enables visualization of body cavities, hollow organs, and canals; instruments perform tissue cutting, manipulation, grasping, and cauterization. Used in clinical settings by surgeons for minimally invasive procedures. Electrosurgical instruments facilitate tissue cautery. System provides smaller diameter alternative to standard endoscopic tools, potentially reducing trauma. Healthcare providers use visual output from endoscope to guide diagnostic and therapeutic interventions.

Clinical Evidence

No clinical data provided. Bench testing only; electrosurgical instruments meet IEC 601-2-18 requirements.

Technological Characteristics

System includes 2.5mm trocar, 2.0mm endoscope, and 2.5mm modular instruments. Electrosurgical instruments comply with IEC 601-2-18. No new technological characteristics beyond reduced diameter compared to existing Aesculap endoscopic product line.

Indications for Use

Indicated for adult and pediatric patients undergoing diagnostic and therapeutic general endoscopy and laparoscopy surgery.

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

• Aesculap Endoscopy Instruments (K942053, K941239, K942730, K940936)
• MicroLap System by Imagyn Medical Inc. (K965055)
• Miniature Laparoscope Set (Mini Lap) by Richard Wolf GMBH (K962799)
• KOH Micro-Suturing Instruments by Karl Storz Endoscopy-America, Inc. (K955479)
• Semi-Rigid Micro Endoscopes and Accessories for Adult and Pediatric General Endoscopic and Laparoscopic Surgery by Karl Storz Endoscopy-America, Inc. (K946164)
• Minisite 2mm Microlaparoscopy System by United States Surgical Corporation (K972415)
• Micro-L Laparoscopy System by Circon Corporation (K unknown)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 3 0 1998

510(k) Premarket Notification

Aesculap Needlescopic Instrument System

Image /page/0/Picture/3 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text reads 'k 98 2623'. The characters are written in a cursive style, and there is a horizontal line underneath the entire string of characters.

Page 1 of 2

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

## AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM

July 27, 1998

Company

Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080

### Contact

Lia S. Jones, Regulatory Associate Phone: [phone] x 350 FAX: [phone]

## Trade Name

Aesculap Needlescopic Instrument System (N.I.S.)

Common Name Endoscope and Accessories

Classification Name and Product Code 78KOG Endoscope and/or Accessories

Product Classification Class II

Requlatory Classification

21 CFR Section 876.1500

#### Intended Use

The Aesculap Needlescopic Instrument System (N.I.S.) is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.

#### Device Description

The system consists of three primary components: a 2.5mm trocar, a 2.0mm endoscope, and 2.5mm modular instruments. The N.I.S. trocar is intended to establish ports through which endoscopes and endoscopic instruments pass into the abdominal cavity. The N.I.S. endoscope is used to examine body cavities, hollow organs and canals, and using additional accessories, to perform various diagnostic and therapeutic procedures. The N.I.S. instruments are used to cut, manipulate, grasp and/or cauterize selected tissue.

{1}------------------------------------------------

Page 2 of 2

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

## AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM

### Summary of Technological Characteristics

Aesculap currently markets a complete endoscopic product line which includes endoscopes and modular trocars and instruments. The Needlescopic Instrument System does not impart any new technological characteristics from the current system other than the reduction in diameter size of the devices.

## Performance Data

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the instruments in Aesculap's Needlescopic Instrument System that are intended for electrosurgery meet the requirements of IEC 601-2-18, the International Electrotechnical Commission Standard for Electrosurgical Devices.

### Substantial Equivalence

Aesculap believes that the Needlescopic Instrument System presented in this submission is substantially equivalent in design, function, and intended use to currently marketed endoscopic systems, such as:

- Aesculap Endoscopy Instruments . by Aesculap (#K942053, #K941239, #K942730, #K940936))
- MicroLap System . by Imagyn Medical Inc. (#K965055)
- Miniature Laparoscope Set (Mini Lap) . by Richard Wolf GMBH (#K962799)
- KOH Micro-Suturing Instruments . by Karl Storz Endoscopy-America, Inc. (#K955479)
- Semi-Rigid Micro Endoscopes and Accessories for Adult and . Pediatric General Endoscopic and Laparoscopic Surgery bv Karl Storz Endoscopy-America. Inc. (#K946164)
- Minisite 2mm Microlaparoscopy System . by United States Surgical Corporation (#K972415)
- Micro-L Laparoscopy System t by Circon Corporation (#K unknown)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Ms. Lia S. Jones Regulatory Associate Aesculap®, Inc. 1000 Gateway Boulevard South San Francisco, California 94080

Re: K982623

Trade Name: Aesculap Needlescopic Instrument System (N.I.S.) Regulatory Class: II Product Code: GCJ Dated: July 27, 1998 Received: July 28, 1998

#### Dear Ms. Jones:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

{3}------------------------------------------------

Page 2 - Ms. Lia S. Jones

If you desire specific advice for your devices 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 devices, 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

{4}------------------------------------------------

510(k) Premarket Notification

Page 1 of 1

# INDICATION FOR USE STATEMENT

510(k) Number (if known):

K982623

Device Name:

1. 11

Aesculap Needlescopic Instrument System

Indication for Use:

Aesculap's Needlescopic Instrument System (N.I.S.) is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.

(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 | K982620 |
| Prescription Use (per 21 CFR 801.109) | or Over-the-Counter Use |

(Optional Format 1-2-96)

り