HEMEDEX CRANIAL BOLT MODELS, 3601, 3602

K032337 · Hemedex Incorporated · GWM · Oct 21, 2003 · Neurology

Device Facts

• Record ID: K032337
• Device Name: HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
• Applicant: Hemedex Incorporated
• Product Code: GWM · Neurology
• Decision Date: Oct 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2

Intended Use

The Hemedex Cranial Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.

Device Story

Hemedex Cranial Bolts are stainless steel threaded cranial access devices; feature standard Tuohy Borst compression fittings. Used to achieve cranial access and secure sensors for intracranial monitoring. Operated by clinicians in a clinical setting. Device provides mechanical access and fixation; does not perform signal processing or data analysis. Benefits include stable sensor positioning for intracranial monitoring.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Stainless steel threaded cranial access devices; includes Tuohy Borst compression fittings. Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring cranial access for the introduction and secure placement of sensors for intracranial monitoring.

Regulatory Classification

Identification

An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

Predicate Devices

• Codman Skull Bolt (K992591)
• Codman Intracranial Bolt (K974088)
• Integra Licox Brain Monitoring System (K002765)
• Codman Disposable ICP Kit with Stainless Steel Screw (Catalog No. 80-1194)

Submission Summary (Full Text)

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OCT 21 2003

K032337 (pg 1 of 1)

## 510K Summary of Safety and Effectiveness

- 1. Sponsor Name:
Hemedex, Inc. 222 Third Street, Suite T123 Cambridge, MA 02142 USA

- 2. Device Name: Hemedex Single Lumen Cranial Bolt Hemedex Double Lumen Cranial Bolt
- 3. Identification of Predicate or Legally Marketed Devices: Codman Skull Bolt (K992591) Codman Intracranial Bolt (K974088) Integra Licox Brain Monitoring System (K002765) Part Number IM1, IM2, IM3 Codman Disposable ICP Kit with Stainless Steel Screw Catalog No. 80-1194
- 4. Device Description: The Hemedex Cranial Bolts are stainless steel threaded cranial access devices with standard tuohy borst compression fittings.

## 5. Intended Use:

The Hemedex Cranial Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.

Comparison of Technological Characteristics The Hemedex Cranial Bolts and the predicate devices use identical technology and materials.

## 7 Performance Testing

Bench testing was conducted to demonstrate that this device meets the requirements of its intended use and meets the specified performance criteria.

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Public Health Service

OCT 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hemedex, Inc. c/o Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K032337

Trade/Device Name: Hemedex Cranial Bolt Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: July 28, 2003 Received: July 31, 2003

Dear Ms. Iampietro:

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 10 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 anmual 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. Debbie Iampietro

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

for Mark N. Mulkerson

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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KO32337 510(k) Number (if known):

Device Name: Hemedex Cranial Bolt

Indications For Use:

The Hemedex Single and Double Lumen Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.

(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 _________________________________________________________________________________________________________________________________________________________

Mark N Mulkern
Division Sign Off

(Division Sign-Off) Dision of General. Restorative the Neurological Devices

i(k) Number_