IO-TOME DEVICE

K113073 · Baxano, Inc. · HAE · Jul 27, 2012 · Neurology

Device Facts

• Record ID: K113073
• Device Name: IO-TOME DEVICE
• Applicant: Baxano, Inc.
• Product Code: HAE · Neurology
• Decision Date: Jul 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iO-Tome Device is used for cutting bone for the purpose of removing a facet joint (facetectomy) of the spinal column.

Device Story

The iO-Tome is a manual surgical instrument designed for lumbar facetectomy. It consists of a proximal handle, a rigid shaft, and a flexible cutting platform featuring two parallel cutting elements on a metallic substrate. Plastic protectors cover the blades during insertion into the foramen. Once positioned using iO-Flex system accessories (iO-Wire, Distal Handle), the user retracts the handles to expose the blades, then performs bimanual reciprocations to cut bone. Used in clinical settings by surgeons to access compromised foraminal areas. The device facilitates bone removal, potentially benefiting patients by relieving foraminal stenosis. It is a modification of the iO-Flex MicroBlade Shaver.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (functional and structural integrity), cadaveric studies, and in vivo porcine testing. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, intracutaneous, systemic toxicity). Sterility validated via e-beam radiation (SAL 10^-6) per ANSI/AAMI/ISO 11137-2. Shelf life and packaging integrity validated per ASTM standards (F1980-07, D4332-01, D4169-08, F2096-04, F88-09).

Technological Characteristics

Flexible, low-profile manual surgical instrument. Components: proximal handle, rigid shaft, flexible metallic cutting platform with parallel blades and plastic protectors. Materials have a history of medical use and meet ISO 10993-1. Sterilization: e-beam radiation. Connectivity: none (manual).

Indications for Use

Indicated for patients requiring facetectomy of the lumbar spinal column.

Regulatory Classification

Identification

A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

Predicate Devices

• iO-Flex MicroBlade Shaver (K113073)

Submission Summary (Full Text)

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K // 3073 .

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JUL 2 7 2012

# 510(K) SUMMARY (21 CFR 807.92) iO-TOME DEVICE

510(k) Owner:

Baxano, Inc. 655 River Oaks Parkway San Jose, CA 95134 Tel: [phone] Fax: [phone]

Contact Person:

Michael Wallace 408.514.2231 [e-mail]

Date Prepared:

Trade Name:

iO-Tome Device Rongeur, Manual

HAE

Class II (21 CFR 882.4840)

iO-Flex MicroBlade Shaver

July 27, 2012

Classification:

Common Name:

Product Code:

Predicate Device Information:

Device Description:

The iO-Tome Device is a design modification of the iO-Flex MicroBlade Shaver. It is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting bone for the purpose of removing a facet joint (facetectomy) in the lumbar spinal column. The flexible cutting platform is comprised of two parallel cutting elements that run along a flat flexible metallic substrate. The metallic substrate has two plastic protectors that temporarily cover the parallel cutting elements during introduction of the device into the foramen and protect the underside of the cutting platform during bimanual reciprocations. After the device is introduced and positioned within the foramen with the use of the iO-Flex System accessories and connected to the iO-Wire and Distal Handle, the user pulls up on the handles thereby exposing the

Baxano, Inc.

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Intended Use:

Technological Characteristics:

Summary of Non-Clinical Performance Data:

Biocompatibility Information:

parallel cutting elements. The user can then proceed with bimanual reciprocations cutting through the targeted facet joint.

The iO-Tome Device is used for cutting bone for the purpose of removing a facet joint (facetectomy) of the lumbar spinal column.

The iO-Tome Device is designed to be a flexible, low profile surgical instrument that allows access to compromised foraminal areas in the lumbar spinal column. The overall design and the fundamental scientific technology is equivalent to the currently cleared predicate MicroBlade Shaver. The FDA cleared iO-Flex technology also includes accessories consisting of the iO-Flex Probe, Neuro Check device, iO-Wire and Distal Handle.

The iO-Tome device was thoroughly tested on the bench to evaluate and verify that it meets its design and performance specifications including biocompatibility, functional and structural integrity.

The bench test plan was developed based on the risk assessment and recommendations outlined in applicable ISO and ASTM standards. Cadaveric and in vivo porcine testing confirmed that the subject device meets all design and performance specifications for its intended use. No new/different safety or effectiveness issues were observed during the testing.

The iO-Tome is classified as an externally communicating device, in short duration contact (≤24 hr) with tissue and bone. Materials used in the construction of the iO-Tome device that come into patient contact have a long history of use in medical applications and were evaluated and tested in compliance with recognized ISO standard ISO 10993-1- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA 21 CFR Part 58 Good Laboratory Practices for Non Clinical Laboratory Study, The Biocompatibility testing performed for the iO-Tome device included the following:

- Cytotoxicity Study - ISO Elution Method - IX MEM Extract
- ISO Guinea Pig Maximization Sensitization Test Extract .
- . ISO Intracutaneous Study in Rabbits - Extract
- ISO Systemic Toxicity Study in Mice Extract Retest .

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All of the pre-determined acceptance criteria were met and results passed.

# Sterility Information:

The iO-Tome Device is delivered sterile applying a validated accelerated e-beam radiation process to achieve a Sterility Assurance Level (SAL) of of 10-6. The following microbiological and irradiation related sterility adoption performance qualification studies were performed in accordance with the following recognized ANSI/AAMI/ISO standards:

Bioburden Recovery Validation Study: ANSI/AAMI/ISO 11737-1:Sterilization of health care products Microbiological methods - Part 1: Determination of the population of microorganisms on product

Bioburden Characterization: ANSI/AAMI/ISO Microbial 11737-1:Sterilization of health care products Microbiological methods - Part 1: Determination of the population of microorganisms on product

Dose Map Verification Study: ANSI/AAMI/ISO Standard 11137-2 - Sterilization of health care products -- Radiation sterilization – Substantiation of 25 kGy as a sterilization dose -Method VDmax

The results of above referenced performance testing on representative product samples successfully demonstrated that the MicroBlade Shaver and iO-Tome are considered to be "Equivalent Product" and can be processed with the same validated routine e-beam irradiation process for dosimetric product release.

The iO-Tome device was not tested for bacterial endotoxins and product labeling does not include any information on pyrogenicity.

Stability testing to determine a minimum shelf life period for product sterility and device integrity was performed according to the following recognized ASTM standards:

ASTM F1980-07: Standard Guide of Accelerated Aging of Sterile Medical Device Packages

ASTM D 4332-01: Conditioning Containers, Packages, or Packaging Components For Testing Standard Practice

Pyrogenicity Information:

Stability Information:

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# AXANC

ASTM D4169-08: Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM F1980-07: Standard Guide of Accelerated Aging of Sterile Medical Device Packages

ASTM F2096-04: Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

ASTM F88-09: Standard Test Method for Seal Strength of Flexible Barrier Material

Substantial Equivalence:

The iO-Tome Device is substantially equivalent to the predicate MicroBlade Shaver. The iO-Tome Device has the same indications for use and conforms to the same fundamental scientific technology as the predicate device. Based upon the same indications for use, technological characteristic, design verification and performance testing results, iO-Tome Device does not raise any new or different questions of safety or effectiveness.

Conclusions: Based on non-clinical performance results including cadaveric and in vivo porcine study data, the iO-Tome Device conforms to all design and performance specification and is substantially equivalent to the predicate MicroBlade Shaver device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Baxano, Inc. c/o Michael Wallace 655 River Oaks Parkway San Jose, California 95134

Re: K113073

Trade/Device Name: i-O Tome Device Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: June 25, 2012 Received: June 27, 2012

#### Dear Mr. Wallace:

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.

JUL 2 7 2012

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## Page 2 - Mr. Michael Wallace

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Deborah Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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"Special 510(k) Notification" (21 CRF 807.90(e)) iO-Flex iO-Tome™ Device

### Indications for Use

510(k) Number (if known):

Device Name: iO-Flex® iO-Tome Device

Indications for Use:

The iO-Tome Device is used for cutting bone for the purpose of removing a facet joint (facetectomy) of the spinal column.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Hoffmann

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K113073

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