PAEDISCOPE, MODEL # P010A AND PF011A

K014149 · Aesculap, Inc. · GWG · Mar 18, 2002 · Neurology

Device Facts

• Record ID: K014149
• Device Name: PAEDISCOPE, MODEL # P010A AND PF011A
• Applicant: Aesculap, Inc.
• Product Code: GWG · Neurology
• Decision Date: Mar 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery and pure neuroendoscopy (i.e. Ventriculosopy) for direct visualization, diagnostic and/or therapeutic neuroendoscopy (i.e. ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

Device Story

Paediscope is a neuroendoscope combining rigid and flexible features; 3.0mm diameter rigid distal end; flexible proximal section with standard light cable/eyepiece adapters. Used in OR by neurosurgeons for direct visualization, diagnostic, and therapeutic procedures (ventriculostomies, biopsies, removal of obstructions). Includes micro-instruments for cutting and grasping. Provides visual feedback to surgeon to guide surgical intervention; benefits patient through minimally invasive access to intracranial structures.

Clinical Evidence

Bench testing only. Evaluation performed for electrical, thermal, and irrigation safety in compliance with IEC 60601-2-18.

Technological Characteristics

Neuroendoscope with 3.0mm rigid distal end and flexible proximal section. Includes operating channel and micro-instruments. Complies with IEC 60601-2-18 for electrical, thermal, and irrigation safety.

Indications for Use

Indicated for use in adult and pediatric patients for endoscope-assisted microneurosurgery and pure neuroendoscopy, including ventriculostomies, biopsies, and removal of cysts, tumors, and other obstructions.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Aesculap MINOP System (K983365)
• Aesculap Ventriculoscope System (K954394)
• Neuro Navigational Neuroview (K954899)
• Medtronic PSMedical Channel Neuroscope (K002572)
• Storz Miniature Neuroendoscope (K002704)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 1 8 2002

in Accordance with SMDA of 1990

## PAEDISCOPE

Kol 4149 1/3

December 12, 2001

| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Georg Keller, Regulatory Affairs Manager<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (email) |
| TRADE NAME: | Paediscope |
| COMMON NAME: | Neuroendoscope |
| DEVICE CLASS: | NEUROENDOSCOPE CLASS II<br>MICRO-INSTRUMENTS – CLASS I EXEMPT |
| PRODUCT CODE: | Neuroendoscope - 84 GWG<br>Micro-Instruments - 84 GZX |
| CLASSIFICATION: | Neuroendoscope - 882.1480<br>Micro-Instruments - 882.4525 |
| REVIEW PANEL: | Neurology |

## INTENDED USE

Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery and pure Aesoulap 3 Paculoope io intendopy) for direct visualization, diagnostic and/or therapeutic noaroonaooopy (nor retriculostomies, biopsies and removal of cysts, tumors and other obstructions.

## DEVICE DESCRIPTION

Aesoulap's Paediscope combines the features of both flexible and rigid scopes. The distal end is a rigid neuroendoscope with a 3.0mm diameter. The rigid part includes one operating channel and nga nedrochaooops with a oroni. The flexible part ends at the standard adapters for light cables and eyepiece connection. The flexible outpatient part allows more flexibility and reduces the weight af the scope part introduced into the patient. The Paediscope can be used in adult and pediatric or the soope part introduced this the patts are included with the Paediscope for the cutting and grasping biopsies and the removal of cysts, tumors and other obstructions.

## PURPOSE FOR SUBMISSION

The purpose for this submission is to gain marketing clearance for the Paediscope.

## PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Paediscope comply with the requirements of IEC60601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The Paediscope has undergone evaluation for electrical, thermal and irrigation safety to ensure the system is safe for the intended use.

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K014149 2/2

## SUBSTANTIAL EQUIVALENCE

The new Paediscope described in this premarket notification is substantially equivalent to those predicate devices:

- Aesculap MINOP System (K983365) .
- Aesculap Ventriculoscope System (K954394) .
- Neuro Navigational Neuroview (K954899) .
- Medtronic PSMedical Channel Neuroscope (K002572) .
- Storz Miniature Neuroendoscope (K002704) .

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human profiles facing right, suggesting a focus on health and human well-being.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2002

Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034

Re: K014149

Trade/Device Name: Paediscope Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: December 15, 2001 Received: December 18, 2001

Dear Mr. Keller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nove ro roved your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of 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 r ou may, dierely mixes 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 (PMA), it If your device to such 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 statutes and regulations administered by other Federal agencies. You must cormply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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# Page 2 – Mr. Georg Keller

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with a a your a finding of substantial equivalence of your device to a legally premated 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

014149

Device Name: Paediscope

## Indication for Use:

Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery Aesculap's Paediscope is Intended for use in officalization, diagnostic and/or and pure neuroendoscopy (t.e. Ventriculosopy) for direct neather in and removal of cysts, tumors and other obstructions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Miriam C. Provost |
|---------------|----------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative |
| | and Neurological Devices |
| 510(k) Number | K014149 |

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

(Optional Format 3-10-98)