DReal

• K Number: K153519
• Device Name: DReal
• Manufacturer: CAREVATURE MEDICAL LTD
• Date Cleared: 2016-03-16 ( 99 days)
• Product Code: HBE
• Regulation Number: 882.4310

Intended Use

The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts < 1 cm3.

Device Description

The DReal™ is a handheld bone-removal device based on a rotating cutter, with a protective shield (hood) partially covering the cutter; following its indications for use, it is designed to cut bone < 1 cm3. The DReal™ comprises a handpiece with a plastic grip ("handle") and a central shaft that curves at its distal end ("tip"). The curved tip is equipped with an active, drill-like cutter that is protected by an extension of the central shaft as a protective shield. The DReal™ has two models, with different angles of curvature at the distal end: Short 45° and Long 75°. Located in the proximal end of the handle, is the motor adaptor (the motor is not part of the supplied product). The DReal™ principles of operation are the same as any other bone cutting tool, as well as the predicate device; it uses electrical or pneumatic power to rotate a cutting element that is approximated to the bone requiring cutting. The DReal™ has an irrigation port on its handle that connects to irrigation source. Irrigation should be running at all times while the DReal™ is active. In case of irrigation malfunction, irrigation can be added externally as with any high-speed, rotating power device, including the predicate. The DReal™ can be powered by an electric or pneumatic motors using a 'micro' adaptor as per ISO 3964; however, it can rotate only clockwise (right-hand, or Forward).

Predicate Devices

K143540

Reference Devices

Stryker Consolidated Operating Room Equipment (CORE) -K112593

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.

Therapeutic

No

The device is a surgical tool designed to cut bone during neurosurgical and spinal procedures, not to treat a disease or medical condition.

Diagnostic

No

The device is described as a surgical tool intended to cut bone, not to diagnose conditions or diseases. Its purpose is to perform actions like drilling, reaming, and shaping bone.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, handheld bone-removal device with a rotating cutter, protective shield, handpiece, shaft, and irrigation port. It is powered by electric or pneumatic motors and is intended for surgical procedures. This is a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Carevature DReal™ is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use clearly states that the device is for cutting bone during surgical procedures (neurosurgical and spinal applications). This is a direct surgical intervention on the patient's body.
• Device Description: The description details a mechanical device with a rotating cutter designed for physical manipulation of bone.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used in vitro (outside the body) to analyze samples. The Carevature DReal™ is used in vivo (inside the body) for surgical purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

March 24, 2016

Carevature Medical, Ltd. Ms. Orly Maor Company Consultant 42nd Tvuot Haarets Street Tel Aviv, Israel 6954648

Re: K153519

Trade/Device Name: DReal™ Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE Dated: February 9, 2016 Received: February 11, 2016

Dear Ms. Orly Maor:

This letter corrects our substantially equivalent letter of March 16, 2016.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153519

Device Name DReal™M

Indications for Use (Describe)

The Carevature DReal™ is intended to be used with high-speed compatible electric and pneumatic motors. When used with these motors, it is intended to cut bone by drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for neurosurgical and spinal applications. Specific applications include laminectomy/laminotomy and craniotomy/craniectomy/ skull base cuts Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Traditional Premarket Notification Submission – 510(k) Summary DReal™ 510(k) Number K153519

I. SUBMITTER

Carevature Medical Ltd. 42 Tvuot Haarets St. Tel Aviv, Israel 6954648 Tel: [phone] Fax: [phone]

Contact Person

Orly Maor Company consultant [e-mail] Tel: [phone] Fax: [phone]nd Tvuot Haarets St. Tel Aviv, Israel 6954648

Date Prepared: February 26, 2016

II. DEVICE

Name of Device: DReal™ Common or Usual Name: DReal™ Classification Name: drills, burrs, trephines & accessories (simple, powered) CFR: 21 CFR §882.4310 Regulatory Class: II Product Code: HBE

III. PREDICATE DEVICE

The predicate device is the Stryker Corporation Stryker MIS Attachments and Cutting Accessories cleared under K143540 (product code HBE, Regulation No. 21 CFR $882.4310).

IV. DEVICE DESCRIPTION

The DReal™ is a handheld bone-removal device based on a rotating cutter, with a protective shield (hood) partially covering the cutter; following its indications for use, it is designed to cut bone