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

AI/ML Overview

Here's an analysis of the provided text regarding the iO-Tome Device, structured to address your specific points:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	All pre-determined acceptance criteria were met, and results passed for Cytotoxicity, Sensitization, Intracutaneous Study, and Systemic Toxicity.
Sterility Assurance Level (SAL)	Achieved an SAL of 10^-6 through validated accelerated e-beam radiation process. Performance qualification studies (Bioburden Recovery Validation, Bioburden Characterization, Dose Map Verification) successfully demonstrated "Equivalent Product" status with predicate, allowing same validated e-beam process.
Stability (Shelf Life & Integrity)	Stability testing performed to determine minimum shelf life for product sterility and device integrity. Specific results are not detailed, but the summary states the device conforms to all design and performance specifications.
Functional & Structural Integrity	Thoroughly tested on the bench to evaluate and verify that it meets its design and performance specifications. 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 observed.
Substantial Equivalence	Device found to be substantially equivalent to the predicate MicroBlade Shaver based on same indications for use, technological characteristics, design verification, and performance testing results. No new or different questions of safety or effectiveness raised.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Biocompatibility: Not explicitly stated, but typically involves a number of samples for each test type (e.g., 3-5 replicates per test for ISO 10993 studies).
- Sterility: Sample size for bioburden, characterization, and dose map verification studies is not specified in the provided text. These studies usually involve a representative number of units from manufacturing lots.
- Stability: Not explicitly stated, but stability studies require a set number of units tested at various time points.
- Functional/Structural (Bench Testing): Not explicitly stated, but generally involves multiple units to demonstrate robustness.
- Cadaveric & In Vivo Porcine Testing: The exact number of cadavers or animals used is not specified.
Data Provenance: Not explicitly stated. The studies are described as "bench tests," "cadaveric," and "in vivo porcine testing." The location where these tests were conducted or the origin of the cadavers/animals is not provided. It is likely prospective testing specifically for this device's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies mentioned (biocompatibility, sterility, stability, functional/structural, cadaveric, in vivo porcine) are primarily engineering and biological performance tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided as the studies described are laboratory and animal model tests, not human clinical studies involving expert adjudication of diagnostic outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted. The iO-Tome device is a surgical instrument (manual rongeur), not an AI-powered diagnostic or imaging tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The iO-Tome is a physical surgical device, not an algorithm. Its performance is inherent in its mechanical function, material properties, and biological interaction, not in a standalone algorithmic capability.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of the iO-Tome device is established through:

Biocompatibility Standards: Compliance with ISO 10993-1 and FDA 21 CFR Part 58, which define established biological responses (e.g., no cytotoxicity, no sensitization).
Sterility Standards: Adherence to ANSI/AAMI/ISO standards (e.g., 11737-1, 11137-2) for demonstrating a specified Sterility Assurance Level (SAL).
Stability Standards: Compliance with ASTM standards (e.g., F1980-07, D4332-01, D4169-08, F2096-04, F88-09) that define accepted methods for evaluating shelf life and package integrity.
Functional/Structural Integrity: Bench test results showing the device meets its design and performance specifications. This implies engineering specifications (e.g., cutting force, flexibility, durability) are the ground truth.
Cadaveric and In Vivo Porcine Testing: Confirmation that the device meets all design and performance specifications for its intended use (cutting bone for facetectomy) in a relevant biological model. This would involve surgical success (e.g., ability to cut the bone as intended, absence of damage to surrounding structures, proper device function without breakage).

8. The sample size for the training set

This is not applicable. The iO-Tome device is a mechanical surgical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven algorithm development. Its design and manufacturing are based on engineering principles and material science, not data training.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this type of device. The design and validation are based on established engineering principles, material properties, and regulatory standards for medical devices.

Summary

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K // 3073 .

Image /page/0/Picture/1 description: The image shows the word "BAXANO" in a bold, sans-serif font. A stylized graphic element intersects the letter "X", resembling a curved line with a small, textured shape at the bottom. The text is horizontally oriented and appears to be a logo or brand name.

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: 408-514-2200 Fax: 408-514-2201

Contact Person:

Michael Wallace 408.514.2231 mwallace@baxano.com

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:

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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Image /page/2/Picture/0 description: The image shows the word "BAXANO" in a bold, sans-serif font. The letters are black against a white background. There is a line going through the letter X.

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

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of 1

Regulation Number and Section

§ 882.4840 Manual rongeur.

(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).