ENDIUS FLEXTIP BLADE

K022578 · Endius, Inc. · HRX · Aug 23, 2002 · Orthopedic

Device Facts

• Record ID: K022578
• Device Name: ENDIUS FLEXTIP BLADE
• Applicant: Endius, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endius® FlexTip® Blade is an articulating soft tissue resector designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies.

Device Story

The Endius FlexTip Blade is a disposable, articulating soft tissue resector used as an accessory to Arthroscopic Micro-discectomy (AMD) systems. It features a flexible tip controlled by a handle lever; an inner shaft rotates within an outer shaft to provide cutting action at the tip. Resected tissue is suctioned through the shaft and handle into an external inline tissue trap. The device is intended for use by surgeons in a clinical setting to perform percutaneous lumbar discectomies. It is supplied sterile for single-use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, articulating soft tissue resector. Features a flexible tip, handle-actuated articulation lever, and rotating inner shaft for cutting. Suction-based tissue removal. Sterile, single-use. Mechanical operation; no software or electronic components.

Indications for Use

Indicated for patients undergoing percutaneous lumbar discectomies using an Arthroscopic Micro-discectomy (AMD) system or compatible drive system.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Endius Endo-Bend Shaver System (K950054)

Submission Summary (Full Text)

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Endius, Inc. Endius® FlexTip™ Blade

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AUG 2 3 2002

# Section 7 - 510(k) Summary

| 7.1<br>Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is<br>required to submit with this Premarket Notification either an "... adequate<br>summary of any information respecting safety and effectiveness or state that<br>such information will be made available upon request of any person." Endius,<br>Inc. chooses to submit a summary of information respecting safety and<br>effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph<br>(A) respecting a device shall contain detailed information regarding data<br>concerning adverse health effects..."<br><br>The summary regarding the adverse health effects of the modified device,<br>Endius® FlexTip® Blade is provided below. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2<br>Submitter | Endius, Inc.<br>23 West Bacon Street<br>Plainville, MA. 02762 |
| 7.3<br>Company<br>Contact | Christine Kuntz-Nassif<br>Director, Regulatory Affairs<br>508-643-0983 Ext. 114 |
| 7.4<br>Device<br>Name | Proprietary Name:<br>Endius® FlexTip® Blade<br>Common Name:<br>Arthroscopic Accessory: Bendable Shaver<br>Classification Name:<br>Arthroscope (HRX) |
| 7.5<br>Predicate<br>Device | Endius Endo-Bend Shaver System: K950054 |
| 7.6<br>Device<br>Description | The Endius FlexTip Blade is a disposable, articulating soft tissue resector<br>designed to be used as an accessory to the Arthroscopic Micro-Discectomy<br>(AMD) System or compatible drive systems. The FlexTip Blade has a flexible<br>portion near the tip, allowing the tip to articulate under control of the lever in<br>the handle. The inner shaft rotates inside the outer shaft providing cutting<br>action through an aperture at the tip. Resected material is suctioned through the<br>inner shaft and shaver handle into an inline external tissue trap. The Endius<br>FlexTip Blade is sold sterile for single-use only. |
| 7.7<br>Device<br>Indications<br>For Use | The Endius® FlexTip® Bladeis an articulating soft tissue resector designed to be<br>used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an<br>equivalent and compatible drive system, to perform percutaneous lumbar<br>discectomies. |
| 7.8<br>Substantial<br>Equivalence | The proposed Endius FlexTip BladeSystem is substantially equivalent to the<br>Endius Endo-Bend System, K950054. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that resemble a person. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 3 2002

Endius, Inc. Christine Kuntz-Nassif Director, Regulatory Affairs 23 West Bacon Street Plainville, Massachusetts 02762

Re: K022578

Trade/Device Name: Endius® Flextip® Blade Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 2, 2002 Received: August 5, 2002

Dear Ms. Kuntz-Nassif:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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 - Ms. Christine Kuntz-Nassif

This letter will allow you to begin marketing your device as described in your Section 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 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" (21 CFR 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,
Mark N Milken

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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510(k) Number (if known):

Device Name: Endius® FlexTip® Blade

### Indications for Use:

The Endius® FlexTip® Blade is an articulating soft tissue resector designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies.

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

Concurence of CDRH, Office of Device Evaluation (ODE)

(Posted July 1, 1998)

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(Optional Format 3-10-98)

Mark A. Milliman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number -