The Noxilizer Surgical Ruler is a 6" x ½" stainless steel surgical ruler with laser engraved markings in both inches and centimeters. The Noxilizer Surgical Ruler is a single-use, sterile device distributed in individuals packages.

AI/ML Overview

The provided text describes the Noxilizer Surgical Ruler and its performance testing to demonstrate substantial equivalence to predicate devices for 510(k) clearance. The document focuses on shelf-life validation and biocompatibility testing. It does not describe AI/algorithm-related acceptance criteria or studies involving human readers or AI assistance. Therefore, a direct answer to the prompt's specific questions about AI performance, multi-reader multi-case studies, and human reader improvement cannot be provided from this text.

However, I can extract information related to the acceptance criteria and study proving the device meets its acceptance criteria, as pertaining to shelf-life and biocompatibility, which are the relevant performance metrics discussed for this device.

Here's a summary of the acceptance criteria and study details for the Noxilizer Surgical Ruler based on the provided text:

Device: Noxilizer Surgical Ruler
Type of Device: Manual measurement device (surgical ruler) - Not an AI/algorithm-based device.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Shelf-Life:
Visual Inspection	No sign of sterile barrier being compromised (per ASTM F1886)	All post-aging samples passed visual inspection.
Tensile Testing	(Sample mean) – k * s ≥ 1.0 pound per linear inch (PLI) (k = 2.566 for 95% confidence, 95% reliability)	All samples had a tensile test value of 2.59 PLI or greater, exceeding the acceptance criteria.
Bubble Leak Testing	No streams of bubbles detected (per ASTM F2096)	All samples tested passed bubble leak testing.
Sterility Testing	All samples negative for growth	All samples were negative for growth at the end of the incubation period.
Biocompatibility:
Cytotoxicity	No biological reactivity (Grade 0) per ISO 10993-5:2009	No biological reactivity (Grade 0) of cells exposed to test article extracts. Test article not considered to have a cytotoxic effect.
Sensitization	Not considered significant (Grade I reaction or less) per ISO 10993-10:2010	Elicited no reaction at the challenge (0% sensitization), classified as having weak allergenic potential (Grade I reaction). Meets requirements.
Irritation	Test article sites do not show a significantly greater biological reaction than control sites per ISO 10993-10:2010	Test article sites did not show a significantly greater biological reaction than control article. Meets requirements.

2. Sample Sizes Used for the Test Set and Data Provenance

Shelf-Life Studies:
- Tensile Testing: "The sample size was sufficient for a 95% confidence interval, 95% reliability." (Specific number not provided, but implies statistical sufficiency).
- Bubble Leak Testing: "The sample size was sufficient for a 90% confidence interval, 95% reliability." (Specific number not provided, but implies statistical sufficiency).
- Sterility Testing: "intact samples" (specific number not provided).
Biocompatibility Studies: "The rulers used as the test articles" (specific number not provided).
Data Provenance: The studies were internal validations and conducted by "outside test houses under GLP conditions." The geographic origin of the data is not explicitly stated but implies US-based testing given the FDA submission. The studies are prospective in nature, as they involve testing newly manufactured devices under controlled conditions to evaluate performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the device is a manual ruler, not an AI or diagnostic device that requires expert ground truth establishment for a diagnostic output. The "ground truth" for the performance tests (e.g., tensile strength, sterility, biological reactivity) is based on quantitative measurements and established biological assays, not expert consensus on images or medical findings.

4. Adjudication Method for the Test Set

This is not applicable for the type of device and testing performed. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in human expert interpretations, typically in diagnostic imaging studies. The testing here involves objective measurements/assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

This is not applicable as the Noxilizer Surgical Ruler is a manual device and does not involve AI assistance or human readers for its intended use.

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

This is not applicable as the Noxilizer Surgical Ruler is a manual device and does not involve any algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these tests consisted of:

Objective Measurements: For shelf-life, this includes physical measurements like tensile strength and absence of leaks.
Established Microbiological Methods: For sterility, this involves culturing samples in SCD media and observing for growth.
Standardized Biological Assays: For biocompatibility, this involves assays detecting cytotoxicity (cell viability), sensitization (allergic response), and irritation (tissue reaction) according to ISO standards. These are laboratory-based, quantitative or semi-quantitative readouts, not expert consensus or pathology reports in the clinical diagnostic sense.

8. The Sample Size for the Training Set

This is not applicable as this is a physical, manual device and does not involve machine learning or training sets.

9. How the Ground Truth for the Training Set was Established

This is not applicable as this is a physical, manual device and does not involve machine learning or training sets.

Summary

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

May 26, 2016

Noxilizer, Inc. Ms. Mary Dadone Vice President of Regulatory Affairs and Quality Assurance 800 West Baltimore Street, Suite 151 Baltimore, MD 21201

Re: K160501

Trade/Device Name: Noxilizer Surgical Ruler Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: Class I Product Code: FTY Dated: April 26, 2016 Received: April 26, 2016

Dear Ms. Mary Dadone:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Mary Dadone.

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K160501
Device Name	Noxilizer Surgical Ruler

Indications for Use (Describe)
The Noxilizer Surgical Ruler is a sterile, single use, manual measurement device intended to be used in various general surgical procedures.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image is a logo for a company called "NOXILIZER". The logo consists of the word "NOXILIZER" in a bold, sans-serif font, with the letters in white against a blue background. To the right of the word is a small "TM" symbol, indicating that the name is trademarked. Above the word "NOXILIZER" is a circular design made up of three concentric circles in a light green color. The background is a solid blue color, providing a strong contrast to the white text and green circles.

510(k) Summary for the Noxilizer Surgical Ruler K160501

Sponsor and 510(k) Owner Noxilizer, Inc. 800 West Baltimore Street, Suite 151 Baltimore, MD USA 21201 Telephone: +1 443 842 4400 Fax: +1 866 316 7791

Contact Person

Mary Dadone Telephone: +1 443 842 4402 e-mail: mdadone@noxilizer.com

Date This Summary Was Prepared May 18, 2016

Name of Device

Trade Name: Noxilizer Surgical Ruler Common Name: Surgical Ruler Regulation Name: Manual surgical instrument for general use (21 CFR 878.4800) Regulatory Classification: Class I Product Code: FTY

Predicate Devices

Richard Allan Surgical Ruler (K790660) Devon Surgical Ruler (K790084)

Device Description

Indications for Use

The Noxilizer Surgical Ruler is a sterile, single use, manual measurement device intended to be used in various general surgical procedures.

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Image /page/4/Picture/0 description: The image is a logo for a company called "NOXILIZER". The logo is set against a blue background. Above the company name is a circular design made up of three concentric circles. The company name is written in a bold, sans-serif font, and the letters are all capitalized. To the right of the company name is the trademark symbol.

Comparison of Device Characteristics

Characteristic	Noxilizer SurgicalRuler	Richard AllanSurgical Ruler	Devon SurgicalRuler
510(k) Number	K160501	K790660	K790084
Product Code	FTY	FTY	FZZ (sold as part of amarking kit)
Intended Use	Measurement in theSurgical Suite	Measurement in theSurgical Suite	Measurement in theSurgical Suite
Length	6 inches/150 mm	6 inches/150 mm	6 inches/150 mm
Sold Sterile	Yes	Optional (per currentadvertising)	Optional (per currentadvertising)
Method ofSterilization	Nitrogen Dioxide	Unknown	Unknown
Single Use	Yes	Yes (currently)	Yes (currently)

The Noxilizer Surgical Ruler differs from the predicates in the materials of construction (stainless steel rather than plastics) and the method of sterilization (nitrogen dioxide sterilization)

Shelf-Life

The Noxilizer Surgical Ruler shelf life of claim of six (6) months has been validated using accelerated aging results. The samples used for the shelf life studies were exposed to a worstcase cycle with the sterilant dose at the upper end of the tolerance limit, high-humidity, elevated temperatures, and extended sterilant dwell times. Accelerated aging was performed in a validated aging chamber per the Q10 Theory and ASTM F1980-07 (2011). The samples were aged at a test temperature of 55°C (±2°C) for 20 days, equivalent to an accelerated aging time of 39.7 days per year with an aging factor (Q10) of 2.0. Sterile barrier properties were evaluated by visual inspection of the pouch package system, tensile testing of the seal, and bubble leak testing.

Visual inspection was performed per ASTM F1886 methods. All post-aging samples were visually inspected, passed the visual inspection, and did not show any sign of the sterile barrier being compromised.

Tensile testing of the seal was performed per ASTM F88 methods using the peak, 180° supported tail method. Both the applied seal and the chevron end of the pouch were tested.

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Image /page/5/Picture/0 description: The image is a logo for a product called "NOXILIZER". The logo consists of the word "NOXILIZER" in a bold, sans-serif font, with the letters in a light color. Above the word is a circular design made up of concentric circles in a light color. The background of the logo is a dark blue color.

The sample size was sufficient for a 95% confidence interval, 95% reliability. The acceptance criteria was as follows:

Accept if (sample mean) – k s ≥ 1.0 pound per linear inch (PLI), otherwise reject. Where:

s = Sample standard deviation
k = 2.566 (k value for 1-sided tolerance limits corresponding to the applicable sample size, confidence, and reliability requirements)

All samples had a tensile test value of 2.59 PLI or greater, and the test results exceeded the acceptance criteria.

Bubble leak testing was performed per ASTM F2096 methods. The sample size was sufficient for a 90% confidence interval, 95% reliability. All samples tested (less control samples) passed bubble leak testing (no streams of bubbles were detected).

Post-aging sterility testing was performed using intact samples incubated for 14 days in SCD media at 28ºC to 32ºC (mesophilic range, corresponding to bioburden test results). All samples were negative for growth at the end of the incubation period.

Biocompatibility

The Noxilizer Surgical Ruler may come into either direct contact with patients' intact skin. That is, it is possible that a surgeon would lay the ruler on intact skin, and it is also possible that the surgeon would touch the ruler and then touch the patient's skin.

The duration of contact is less than 24 hours
. The site of contact is intact skin only

Therefore, per the Agency's most recent published draft quidance concerning selection of biocompatibility tests and the recommendations of ISO 10993-1:2009, the following biocompatibility testing was performed:

Cytotoxicity
Sensitization .
Irritation or Intracutaneous Reactivity ●

ี Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" – Draft Guidance for Industry and Food and Drug Administration Staff, issued on April 23, 2013

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Image /page/6/Picture/0 description: The image is a logo for a company called "NOXILIZER". The logo is set against a blue background. Above the company name is a symbol consisting of four concentric circles in a light green color. The company name is written in a bold, sans-serif font, with the letters in white. To the right of the company name is the trademark symbol.

The rulers used as the test articles for the biocompatibility tests were manufactured in accordance with the specified manufacturing process. The rulers were then exposed to a highend worst-case, full-cycle session, where the sterilant dose, the humid air set point pressure, the dwell time, and the temperature were all manipulated to result in exposures at or above the higher limits specified in the sterilization process specification for the Noxilizer Surgical Ruler.

The exposed rulers were then evaluated by outside test houses under GLP conditions. Cytotoxicity testing was performed in accordance with the requirements of ISO 10993-5:2009; sensitization and irritation testing were performed in accordance with the requirements of ISO 10993-10:2010. The biocompatibility test results are summarized below.

Cytotoxicity testing was performed under GLP conditions using ISO MEM elution and L-920 Mouse Fibroblast Cells. Extraction was performed in E-MEM+ 5% FBS. The test article was incubated in the extraction vehicle for 24 ± 2 hours at 37 ± 1 ℃ in a humidified atmosphere of 5 ± 1% CO2 in air. There was no biological reactivity (Grade 0) of the cells exposed to the test article extracts. The response obtained from the positive and negative control article extracts confirmed the suitability of the test system. Based on the criteria of the protocol and the ISO 10993-5 guidelines, the test article meets the requirements of the test and is not considered to have a cytotoxic effect.

Sensitization testing was performed under GLP conditions following the ISO Guinea Pig Maximization Sensitization Test with two extracts, one in NaCl and one in cottonseed oil. The test articles were incubated in the respective extraction vehicle for 72 ± 2 hours at 50 ± 2ºC. The USP 0.9% Sodium Chloride for Injection (NaCI) and Cottonseed Oil (CSO) extracts of the test article, Ruler 6.0", 316 SSTL, elicited no reaction at the challenge (0% sensitization), following an induction phase. Therefore, as defined by the scoring system of Kligman, this is a Grade I reaction and the test article is classified as having weak allergenic potential. Based on the criteria of the protocol, a Grade I sensitization rate is not considered significant and the test article meets the requirements of the ISO 10993-10 guidelines.

Irritation testing was performed under GLP conditions following the ISO Intracutaneous Irritation Test method with two extracts, one in NaCl and one in soybean oil. The test articles were incubated in the respective extraction vehicle for 72 ± 2 hours at 50 ± 2ºC. The USP 0.9% Sodium Chloride for Injection (NaCI) and Cottonseed Oil (CSO) extracts of the test article, Ruler 6.0", 316 SSTOL, were evaluated for their potential to produce irritation after intracutaneous injection in New Zealand White rabbits. The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. Based on the protocol, the test article meets the requirements of the ISO 10993-10 guidelines.

Conclusion: No new issues of safety or effectiveness have been raised, based on the nonclinical tests performed. The performance testing data for the subject device, Noxilizer Surgical Ruler demonstrates

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that the subject device is as safe, as effective and performs as well as the legally marketed predicate devices.

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.