The single use CAAP (Calcium Apatite) Bone Wax sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula). CAAP Bone Wax is to be mixed immediately prior to use.

AI/ML Overview

The provided text describes a 510(k) summary for the CAAP (Calcium Apatite) Bone Wax, asserting its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study sizes, ground truth establishment, and MRMC studies is not available in the given document.

The document states: "CAAP Bone Wax does not require clinical test."

However, it does mention non-clinical tests. Here's a breakdown of what information can be extracted and what cannot:

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

Acceptance Criteria (from non-clinical tests)	Reported Device Performance
Biocompatibility (standard set forth in ISO 10993-1)	CAAP Bone Wax is in accordance with ISO 10993-1.
Radiation sterilization validation (compliance to ANSI/AAMI/ISO 11137-2:2006)	Radiation sterilization validation is in compliance to ANSI/AAMI/ISO 11137-2:2006.
Physiological pH and temperature range (bench testing)	Bench testing demonstrated that CAAP Bone Wax remains within the physiological pH and temperature range and would be expected to show no adverse biological consequence.
Adequate hemostasis as a mechanical tamponade compared to predicate devices (animal study)	The animal study provided substantial data that the use of CAAP Bone Wax as a mechanical tamponade to control bleeding in a bony site results in adequate hemostasis as compared with the predicate devices.

2. Sample size used for the test set and the data provenance

Test set sample size: Not specified. The document mentions an "animal study" but does not detail the number of animals or specific experimental setup.
Data provenance: Not specified beyond "animal study." No information on country of origin or whether it was retrospective/prospective.

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

Not applicable/Not specified. The document does not describe a human-read test set or expert ground truth establishment for the animal study.

4. Adjudication method for the test set

Not applicable/Not specified.

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

No. This is not a study involving AI or human readers. The document states, "CAAP Bone Wax does not require clinical test."

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

Not applicable. This is not about an algorithm or AI.

7. The type of ground truth used

For the animal study: The ground truth was based on the observed "adequate hemostasis" in comparison to predicate devices, implying a functional outcome assessment by the researchers conducting the study. No mention of pathology or other objective measures for this comparison.
For biocompatibility and sterilization: Ground truth is compliance with specified ISO standards.
For bench testing: Ground truth is remaining within physiological pH and temperature ranges.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows handwritten text including "K111538" and "p1/2". Below this, the date "OCT 25 2011" is written. The text appears to be written in black ink on a white background. The handwriting is somewhat stylized, with distinct letter formations.

Image /page/0/Picture/1 description: The image shows a logo with a circular graphic on the left and the words "Skeletal Kinetics" on the right. The circular graphic resembles a globe with intersecting lines. The text "Skeletal Kinetics" is stacked, with "Skeletal" on top of "Kinetics", and both words are in a bold, sans-serif font.

A COLSON ASSOCIATE

Product Code:

510(k) Summary

General Information as required by 21 CFR 807.92 (a) (1)

Christine Kuo, Contact Person: Director, Regulatory Affairs and Quality Assurance Phone: (408) 350-5842, Fax: (408) 366-1077

September 22, 2011 Date Prepared:

Device Name as required by 21 CFR 807.92 (a) (2)

Trade Names:	CAAP (Calcium Apatite) Bone Wax
Common Name:	Calcium phosphate bone wax
Classification:	Unclassified

MTJ

Predicate Devices as required by 21 CFR 807.92 (a) (3)

The subject device is substantially equivalent in safety and effectiveness to the following legally marketed devices (predicates):

I. Auto Suture Bone Wax	K971680
II. Ostene	K062280
III. Ethicon Bone Wax	Preamendment
IV. Lukens Bone Wax	K791495

Device Description as required by 21 CFR 807.92 (a) (4)

Intended Use as required by 21 CFR 807.92 (a) (5)

CAAP Bone Wax is indicated to control the bleeding from cut or damaged bone by

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acting as a mechanical barrier or tamponade.

..............................................................................................................................................................................

Summary of Technological Characteristics as required by 21 CFR 807.92 (a) (6)

CAAP Bone Wax is composed of calcium phosphate and sodium silicate solution, when mixed together it forms a paste that can be applied directly to sites of bleeding bone, the resulting hardening material from the paste is composed of hydroxyapatite similar to the mineral phase of native bone tissue.

CAAP Bone Wax is substantially equivalent to previously cleared bone wax devices believed to control the bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Predicate device I, K971680, Auto Suture Bone Wax (U.S. Surgical) is indicated in the control of bleeding from bone surfaces.

Predicate device II, K062280, Ostene (Ceremed) is indicated for use in the control of bleeding from bone surfaces.

Predicate device III, preamendment, Bone Wax (Ethicon Surgical) is to control bleeding from bone.

Predicate device IV, K791495, Lukens Bone Wax (Lukens) is acts as a mechanical barrier in achieving hemostasis in bleeding bone.

Summary of Non-clinical Tests as required by 21 CFR 807.92 (b) (1)

The biocompatibility of CAAP Bone Wax is in accordance with the standard set forth in ISO 10993-1, Biological Evaluation of Medical Devices and the radiation sterilization validation is in compliance to ANSVAAMI/ISO 11137-2:2006, Sterilization of Health Care Products - Radiation - Establishing the Sterilization Dose.

The results of bench testing demonstrated that CAAP Bone Wax remains within the physiological pH and temperature range and would be expected to show no adverse biological consequence when applied as a physical hemostatic material.

The animal study provided substantial data that the use of CAAP Bone Wax as a mechanical tamponade to control bleeding in a bony site results in adequate hemostasis as compared with the predicate devices.

Summary of Clinical Tests as required by 21 CFR 807.92 (b) (2)

CAAP Bone Wax does not require clinical test.

Conclusion as required by 21 CFR 807.92 (3)

The summary demonstrates that CAAP Bone Wax is substantially equivalent to the predicate devices and is as safe, as effective and performs as well as the legally market devices identified.

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

OCT 25 2011

Skeletal Kinetics LLC % Ms. Christine Kuo Director, Regulatory Affairs and Quality Assurance 10201 Bubb Road Cupertino, California 95014

Re: K111538

Trade/Device Name: CAAP (Calcium Apatite) Bone Wax Regulatory Class: Unclassified Product Code: MTJ Dated: September 22, 2011 Received: September 23, 2011

Dear Ms. Kuo:

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 devire (ran 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 af the Act or any Federal statutes and regulations administered by other Federal agencies. Your must

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Page 2 - Ms. Christine Kuo

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 note the regalations 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Emil Keith

Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use

510(K) Number (if Known): K11538

Device Name:

CAAP (Calcium Apatite) Bone Wax

Indications for Use:

CAAP (Calcium Apatite) Bone Wax is indicated to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Prescription Use x (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21CFR 801 Subpart C

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E. Keith

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111538

Regulation Number and Section

N/A