FRAMELOCK; FRAMELOCK ACCESSORIES

K022370 · Medtronic Xomed, Inc. · HBG · Oct 18, 2002 · Neurology

Device Facts

• Record ID: K022370
• Device Name: FRAMELOCK; FRAMELOCK ACCESSORIES
• Applicant: Medtronic Xomed, Inc.
• Product Code: HBG · Neurology
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4300
• Device Class: Class 2

Intended Use

The FrameLock™ is indicated for otorhinolaryngological and head/neck surgery where any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomic head or neck structure, such as the skull, vertebrae, intranasal area, or sinus, can be identified relative to a CT or MR based model of the anatomy.

Device Story

FrameLock is an accessory to the LandmarX Image Guided Surgical System. It provides rigid fixation for the LandmarX reference arc to the patient's skull. The device consists of a titanium screw, manual stainless steel drill, and associated cannulation nuts. Operation involves drilling a pilot hole into the skull via a small percutaneous incision, then securing the FrameLock assembly. It allows for navigation using a sterile drape technique. Used in surgical settings by clinicians to maintain spatial registration between the patient's anatomy and pre-operative CT/MR models, facilitating image-guided surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials include titanium (screws) and stainless steel (manual drill). The device is a manual surgical instrument kit. It is non-powered and does not involve electronic sensing or software. Sterilization is performed via standard tray methods.

Indications for Use

Indicated for patients undergoing otorhinolaryngological or head/neck surgery requiring stereotactic navigation where rigid anatomical reference points (skull, vertebrae, intranasal area, or sinus) can be correlated to CT or MR imaging.

Regulatory Classification

Identification

Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

Predicate Devices

• Medtronic hand drill bits (K904283)

Reference Devices

• LandmarX Image Guided Surgical System (K992927)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo features a stylized human figure in motion, depicted as a series of overlapping silhouettes within a circle. Below the emblem, the word "Medtronic" is written in a bold, sans-serif font.

1.0

OCT 1 8 2002

Ko 22370 1/

Medtronic Xomed 6743 Southpoint Dr. N Jacksonville, Florida 32216-0980

tel [phone]

Summary

Summary statement in accordance with the Safe Medical Devices Act (SMDA) 19 July 2002 Date Prepared

- B. L. McDermott, RAC 2.0 Submitter (Contact) Senior Regulatory Affairs Specialist Medtronic Xomed, Inc. Jacksonville FL 32116.0980 904.332.8562
#### 3.0 Device Names and Classifications

Classification for the (1) FrameLock™ and (2) FrameLock™ accessories is under two generic names:

- (1) Cranial drill handpiece (brace)
- (2) Manual cranial drills, burrs, trephines, and their accessories

#### Device Names and Classifications for FrameLock Kit Table 1

| Item | REF | Device Name | Reg. Number | Reg. Class |
|------|---------|----------------------------------------|-------------------|------------|
| 1 | 960-811 | FrameLock Kit | (Listed by parts) | II |
| 2 | 960-808 | FrameLock | 21 CFR 882.4325 | I exempt |
| 3 | 960-802 | Screws | 21 CFR 882.4300 | II |
| 4 | 960-368 | Guide Pin | 21 CFR 882.4300 | II |
| 5 | 960-803 | Screwdriver | 21 CFR 882.4300 | II |
| 6 | 960-804 | Drill Assembly (current) | 21 CFR 882.4300 | II |
| 7 | 960-806 | Sterilization Tray (current) | 21 CFR 882.4300 | II |
| 8 | 960-807 | Open Cannulation Nut | 21 CFR 882.4325 | I exempt |
| 9 | 960-707 | Closed Cannulation Nut | 21 CFR 882.4300 | II |
| 10 | 960369 | LandmarX Modular Drill Handle (future) | 21 CFR 882.4300 | II |
| 11 | 960371 | LandmarX Modular Drill Bit (future) | 21 CFR 882.4300 | II |
| 12 | 960374 | FrameLock Sterilization Tray (future) | 21 CFR 882.4300 | II |

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K022370 2/2

Medtronic Xom 6743 Southpoint Dr. N Jacksonville, Florida 32216-0980

tel [phone]

Image /page/1/Picture/3 description: The image shows the Medtronic XOMED logo. The logo features a stylized graphic of a person with outstretched arms inside a circle above the word "Medtronic" in a bold, sans-serif font. Below "Medtronic" is the word "XOMED" in a smaller, sans-serif font.

Summary (continued)

### 4.0 Device Description

The LandmarX™ FrameLock™ kit is an optional accessory of the LandmarX Image Guided Surgical System, previously cleared in K992927

The LandmarX™ FrameLock™ kit is designed to provide a safe, reliable, compact, and minimally invasive means of direct and rigid fixation to the patient's skull for the LandmarX™ reference arc (REF # 960-632). The FrameLock™ mounts using a titanium screw entering a pilot hole drilled with stainless steel manual drill and accessories. A small percutaneous incision is adequate to install the device. The FrameLock also permits navigation using the sterile drape technique.

#### Indications for Use 5.0

The FrameLock™ is indicated for otorhinolaryngological and head/neck surgery where any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomic head or neck structure, such as the skull, vertebrae, intranasal area, or sinus, can be identified relative to a CT or MR based model of the anatomy.

## Substantial Equivalence 6.0

The drill and screws in the FrameLock kit have design, technology, features, function and intended use of manual cranial drills and their accessories with Substantial Equivalence (SE) to Medtronic hand drill bits [K904283], currently marketed in the Medtronic PS Medical Ventriculostomy Kit.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 8 2002

Medtronic Xomed, Inc. B. L. McDermott, RAC Senior Regulatory Affairs Specialist 6743 Southpoint Drive, North Jacksonville, Florida 32216-0980

Re: K022370

Trade/Device Name: Framelock™ Regulation Number: 882.4300 Regulation Name: Manual cranial drills, burrs, trephines and their accessories Regulatory Class: II Product Code: HBG Dated: July 19, 2002 Received: July 22, 2002

Dear Mr. McDermott:

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 – Mr. B. L. McDermott

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,

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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| Page | of |
|------|----|
|------|----|

| S10(k) NUMBER (IF KNOWN) : | K022370 |
|----------------------------|-----------|
| DEVICE NAME: | FrameLock |
| INDICATIONS FOR USE: | |

The FrameLock™ is indicated for otorhinolaryngological and head/neck surgery where any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomic head or neck structure, such as the skull, vertebrae, intranasal area, or sinus, can be identified relative to a CT or MR based model of the anatomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-91

uriam C. Provost

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

510(k) Number K022370