The KyphX® HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

Device Description

Like the predicate device, KyphX® HV-R bonc coment is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl pcroxide as an initiator. The liquid component consists ી methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device, the KyphX® HV-R bone cement. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and a detailed performance study as would be seen for new or high-risk devices.

Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, detailed study design for proving performance, and ground truth establishment is not available in this document.

Here's a breakdown of what can be extracted and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate)	Reported Device Performance
Chemical Composition	Substantially equivalent to Surgical Simplex® P (predicate device) in formulation.	Powder: PMMA/methyl methacrylate-styrene copolymer (68.0% w/w), Barium sulfate (30.0% w/w), Benzoyl peroxide (2.0% w/w). Liquid: Methyl methacrylate (99.1% v/v), N, N-dimethyl-p-toluidine (0.90% v/v), Hydroquinone (75 ppm). These values are provided and compared to the predicate in Table 5-1, indicating equivalence.
Mechanical Properties	Verified substantially equivalent to predicate device as defined by ISO 5833:2002 ("Implants for Surgery - Acrylic resin cements").	"KyphX® HV-R bone cement was tested in direct comparison to the predicate device and verified substantially equivalent." (Specific quantitative data not provided in this summary.)
Biocompatibility	Meet requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" per FDA Blue Book Memorandum #G95-1, and substantially equivalent to predicate device as defined by ISO-10993.	"KyphX® HV-R bone cement was tested in direct comparison to the predicate device and verified substantially equivalent." (Specific test results not provided.) "The materials used...meet the requirements for 'Implant, Tissue/Dentin/Bone, Permanent Contact' described in the FDA Blue Book Memorandum #G95-1."
Sterilization	Sterile and non-pyrogenic with specified Sterility Assurance Levels (SAL).	"The KyphX® HV-R bone cement is sterile and non-pyrogenic." Solid components: gamma radiation to SAL of 10⁻⁶. Liquid components: filtration methods to SAL of 10⁻³. Outer packaging: ethylene oxide gas.
Intended Use	Substantially equivalent to the predicate indication for the fixation of pathological fractures and does not adversely impact safety or effectiveness.	"The KyphX® HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure." Clinical information "demonstrates that the intended use...is substantially equivalent to the predicate indication."

Information Not Provided in the Document:

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

This document does not detail specific "test sets" for a clinical study in the way an AI/software device would. The comparisons are primarily based on material properties, biocompatibility, and intended use equivalence to a predicate device. If mechanical or biocompatibility tests involved samples, those sample sizes are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable in this context. Ground truth establishment for a diagnostic AI is not part of a bone cement's 510(k) submission.

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

Not applicable.

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:

Not applicable. This device is bone cement, not an AI or software product.

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

Not applicable.

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

The "ground truth" here is the established performance and safety profile of the predicate device (Surgical Simplex®P) and adherence to recognized standards (ISO 5833:2002, ISO-10993, FDA Blue Book Memorandum #G95-1). It's not about a diagnostic outcome for a patient.

8. The sample size for the training set:

Not applicable. There is no AI model or training set involved.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the KyphX® HV-R bone cement meets its (implicit) acceptance criteria is a direct comparison study against a legally marketed predicate device, Surgical Simplex® P. This comparison focused on:

Chemical Composition: Comparing the exact percentages of components (PMMA copolymer, barium sulfate, benzoyl peroxide in the powder; methyl methacrylate, N,N-dimethyl-p-toluidine, hydroquinone in the liquid). The provided table (Table 5-1) serves as the evidence for this.
Mechanical Properties: Testing performed in accordance with ISO 5833:2002, demonstrating "substantial equivalence" to the predicate. (Specific test results are not detailed in this summary).
Biocompatibility: Evaluation against FDA Blue Book Memorandum #G95-1 and comparison to the predicate as defined by ISO-10993, demonstrating "substantial equivalence."
Sterilization: Verification of sterility and non-pyrogenicity, with specific details on methods and SALs.
Intended Use: Clinical information was reviewed to confirm that the new device's intended use is substantially equivalent to the predicate's and does not negatively impact safety or effectiveness.

The conclusion is that the KyphX® HV-R bone cement is substantially equivalent to the predicate device based on these comparisons, allowing it to be cleared for market without requiring a full PMA (Premarket Approval) application.

Summary

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Tab 5

Premarket Notification [510(k)] Summary

Trade Name:	KyphX® HV-R bone cement
Common Name:	Bone Cement
Classification /Name:	Class IIBone Cement: 21 CFR, part 888.3027
Device Code:	LOD
Manufacturer's Name:	Kyphon Inc.
Address:	1350 Bordeaux DriveSunnyvale, CA 94089
Corresponding Official:	Richard W. Mott
Title:	President and CEO
Address:	1350 Bordeaux DriveSunnyvale, CA 94089
Telephone:	408-548-6500
Predicate Device(s):	K002652:	Stryker Howmedica Surgical Simplex®PRadiopaque pre-packed in ACM and MixEvac II.
	N017004:	Howmedica Osteonics Surgical Simplex®PRadiopaque Bone Cement
Intended Use:	The KyphX® HV-R bone cement is indicated for thetreatment of pathological fractures of the vertebral bodydue to osteoporosis using a kyphoplasty procedure.

CONFIDENTIAL

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product can be lawfully market without premarket approval or reclassification, and is not intended to be inferpreted as an admission or any other type of evidence in patent infringement litigation. The present submission is therefore not related to the coverage of any patent or whether these products or their uses may be considered distinct from a patent point of view.

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K033801 Page 2 of 3

Like the predicate device, KyphX® HV-R bonc coment is Device Description: provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate as a radiopacifier and benzoyl pcroxide as an initiator. The liquid component consists ી methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.

Table 5-1 compares the chemical composition of KyphX00 HV-R to the predicate device.

Chemical Composition	KyphX® HV-R	Surgical Simplex® P
Powder	20 g. packet of sterile powder	20 g (half-dose) packet of sterilepowder
Polymethyl methacrylate/ methyl methacrylate-styrene copolymer	68.0% w/w	88.5% w/w
Barium sulfate	30.0% w/w	10.0% w/w
Benzoyl peroxide	2.0% w/w	1.5% w/w
Liquid	10 ml vial of sterile liquid	10 ml (half-dose) vial of sterileliquid
Methyl methacrylate(monomer)	99.1% v/v	97.4% v/v
N, N-dimethyl-p-toluidine	0.90% v/v	2.6% v/v
Hydroquinone	75 ppm	75 ± 15 ppm

Table 5-1: Chemical Composition of KyphX® HV-R and Surgical Simplex®P

Mechanical Tcsts:

KyphX® HV-R bone cement was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, "Implants for Surgery - Acrylic resin cements."

CONFIDENTIAL

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product can be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. The present submission is therefore not related to the coverage of any patent or whether these products or their uses may be considered distinct from a patent point of view.

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Clinical information demonstrates that the intended use of Clinical Discussion: KyphX® HV-R is substantially equivalent to the predicate indication for the fixation of pathological fractures and does not adversely impact safety or effectiveness.
Biocompatibility: The materials used in KyphX HV-R meet the requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" described in the FDA Blue Book Memorandum #G95-1. KyphX® HV-R bone cement was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by 1SO-10993. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
The KyphX® HV-R bone cement is sterile and non-Sterilization: pyrogenic. The solid components and pouch are sterilized with gamma radiation to a Sterility Assurance Level (SAL) of 10°. The liquid components are sterilized with filtration methods to an SAL of 10-3. The outer packaging containing the liquid component is sterilized with ethylene oxide gas. The bone cement is intended for single use only.
Substantial Equivalence: The information submitted in this pre-market notification supports a determination that KyphX® HV-R bone cement is substantially equivalent in technological characteristics and intended use to the predicate, Surgical Simplex®P. The products have the same fundamental scientific technology in their chemical composition, matcrial properties, performance characteristics, biocompatibility and clinical application.

CONFIDENTIAL

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product can be lawfully marketed without premarket approval or reclassification, and is not intended to the interpreted as an admission or any other type of evidence in patent infringement litigation. The present submission is therefore not related to the coverage of any patent or whether these products or their uses may be considered distinct from a patent point of view.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Cindy Domecus Vice President, Clinical Research and Regulatory Affairs Kyphon, Inc. 1350 Bordeaux Drive Sunnyvale, California 94089

Re: K033801

Trade/Device Name: KyphX HV-R, Model C01A Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: February 24, 2004 Received: February 25, 2004

Dear Ms. Domecus:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Milkens

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Amendment to K033801 Revised Indications for Use March 30, 2004

Indications for Use

510(k) Number (if known): K033801

Device Name: KyphX® HV-R Bone Cement

Indications for Use:

The KyphX® HV-R Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure.

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

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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

Page 1 of 1

510(k) Number K033801

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”