(23 days)
KyphX® HV-R™ bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemagioma and giant cell tumor.
Like the predicate devices, KyphX® HV-RTM Bone Cement 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 peroxide as an initiator. The liquid component consists of 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.
The provided text is a 510(k) Premarket Notification Summary for a medical device (KyphX® HV-R™ Bone Cement) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way one might expect for an AI/ML medical device.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of:
- Chemical Composition: Comparing the ingredients and their percentages.
- Mechanical Tests: Verifying equivalence as defined by ISO 5833:2002 ("Implants for Surgery - Acrylic resin cements").
- Biocompatibility: Meeting requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" as described in FDA Blue Book Memorandum #G95-1 and verified as substantially equivalent to the predicate device per ISO-10993.
- Sterilization: Describing sterilization methods and Sterility Assurance Levels (SAL).
- Intended Use: Showing that the intended use is substantially equivalent to predicate devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or not explicitly detailed in this type of submission, as it's not a study validating AI performance. The "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence for this specific type of device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (KyphX® HV-R™ Bone Cement) |
|---|---|
| Material Composition Equivalence | 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 monomer (99.1% v/v), N, N-dimethyl-p-toluidine (0.90% v/v), Hydroquinone (75 ppm). Compared to Surgical Simplex® P predicate device composition in Table 5-1 and found to be "substantially equivalent" in chemical composition and material properties. |
| Mechanical Performance Equivalence | Tested in direct comparison to Surgical Simplex® P predicate device and verified substantially equivalent as defined by ISO 5833:2002, "Implants for Surgery - Acrylic resin cements." (Specific performance metrics and thresholds from ISO 5833:2002 are not explicitly listed in the submission, but compliance to the standard is stated). |
| Biocompatibility Equivalence | Materials meet requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" described in FDA Blue Book Memorandum #G95-1. Tested in direct comparison to Surgical Simplex® P predicate device and verified substantially equivalent as defined by ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." (Specific tests and results from ISO-10993 are not explicitly listed, but compliance to the standard and FDA memorandum is stated). |
| Sterilization Efficacy | Solid components/pouch: Sterilized with gamma radiation to an SAL of 10⁻⁶.Liquid components: Sterilized with filtration methods to an SAL of 10⁻⁵.Outer packaging: Sterilized with ethylene oxide gas. Device is sterile and non-pyrogenic, intended for single use. |
| Intended Use Equivalence | Intended use for treatment of pathological vertebral body fractures (due to osteoporosis, cancer, or benign lesions using balloon kyphoplasty) is substantially equivalent to the indications of the Surgical Simplex® P, KyphX® HV-R™ (predicate), and Spineplex™ bone cements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "mechanical tests" and "biocompatibility tests" but does not detail the sample sizes or data provenance for these tests. It indicates the tests were done "in direct comparison" to a predicate device.
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)
This is not applicable to this type of device submission. The "ground truth" here is defined by objective engineering and biocompatibility standards (ISO 5833:2002, ISO 10993, FDA G95-1 Memorandum) rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The assessment for substantial equivalence for this device is based on laboratory-derived physical and chemical properties and biocompatibility, not on human interpretation or adjudication processes typical for diagnostic AI devices.
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
This is not applicable. This is a bone cement device, not an AI/ML diagnostic tool, so no MRMC study would be performed for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a material-based medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international standards and regulatory guidelines for bone cements and medical device biocompatibility, specifically:
- ISO 5833:2002 ("Implants for Surgery - Acrylic resin cements") for mechanical properties.
- ISO-10993 ("Biological Evaluation of Medical Devices Part 1: Evaluation and Testing") for biocompatibility.
- FDA Blue Book Memorandum #G95-1 for biocompatibility requirements for permanent contact implants.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process in the context of machine learning.
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Kyphon Inc Page 1 of 3, Amended Tab 5 KyphX® HV-RTM Bone Cement Premarket Notification [510(k)] Submission
JUL = 7 2004
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: | NDN |
| Manufacturer's Name:Address: | Kyphon Inc.1221 Crossman AvenueSunnyvale, CA 94089 |
| Corresponding Official:Title:Address:Telephone: | Cindy DomecusVice President, Clinical Research and Regulatory Affairs1221 Crossman AvenueSunnyvale, CA 94089408-222-6740 |
| Predicate Device(s): | K033801: KyphX® HV-R™, Model C01AK002652: Stryker Howmedica Surgical Simplex®Radiopaque pre-packed in ACM and MixEvac II.K032945: Stryker Spineplex™ Radiopaque Bone Cement |
| Intended Use: | KyphX® HV-R™ bone cement is indicated for thetreatment of pathological fractures of the vertebral bodydue to osteoporosis, cancer, or benign lesions using aballoon kyphoplasty procedure. Cancer includes multiplemyeloma and metastatic lesions, including those arisingfrom breast or lung cancer, or lymphoma. Benign lesion- |
Any statement regarding "substantial equivalence" made in this submission only relates to whether the intended to be interested in this submission may be lawfully market approval or reclassification, and is not intended o be interpreted as an admission of evidence in any patent proceeding, and is not infingement therein therefore should not be consider and of the scope of any patent or patent or patent or patent or patent opplication, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.
include hemagioma and giant cell tumor.
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Like the predicate devices, KyphX® HV-RTM Bone Cement Device Description: 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 peroxide as an The liquid component consists initiator. of 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 KyphX® HV-RTM Bone Cement to the Surgical Simplex® P predicate device.
| Table 5-1: Chemical Composition of KyphX® HV-R and Surgical Simplex®P | |||
|---|---|---|---|
| Chemical Composition | KyphX® HV-RTM | Surgical Simplex® P |
|---|---|---|
| Powder | 20 g. packet of sterile powder | 20 g (half-dose) packet of sterile powder |
| 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 sterile liquid |
| 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 |
Mechanical Tests:
KyphX® HV-R™ Bone Cement was tested in direct comparison to the Surgical Simplex® P predicate device and verified substantially equivalent, as defined by ISO 5833:2002, "Implants for Surgery - Acrylic resin cements."
Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully market approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement fitigation or proceeding before any Patent office. The present submission and statements therein the product not be construed as affecting or help to the scope of any patent or patent or patent or patent or patent or patent or patent or patent opplication, or to whether the product addressed in this submission, or its use, any parent application, of the laboration, from a a atentability perspective, from any of the other devices referenced in this filing.
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- Clinical information demonstrates that the intended use of Clinical Discussion: KyphX® HV-RTM Bone Cement is substantially equivalent to the Surgical Simplex® P indication for the fixation of pathological fractures, to the KyphX® HV-R™ predicate indication for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure, and to the Spineplex™ bone cement for use in benign and metastatic lesions.
The materials used in KyphX® HV-R™ Bone Cement meet Biocompatibility: the requirements for "Implant, Tissue/Dentin/Bone, Permanent Contact" described in the FDA Blue Book Memorandum #G95-1. KyphX® HV-RTM Bone Cement was tested in direct comparison to the Surgical Simplex® P predicate device and verified substantially equivalent, as defined by ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
The KyphX® HV-RTM 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 10-5. 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-RTM Bone Cement is substantially equivalent in technological characteristics and intended use to the predicates. The products have the same fundamental scientific technology their chemical composition, material properties, in performance characteristics, and biocompatibility, and also have the same intended use.
Any statement regarding "substantial equivalence" made in this submission only relates to whether the intended to be interest without may 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 any petent proceeding, including paract infringement litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the "stennssion and "statinlerity whether the product addressed in this submission, or its use, may be considered indistinct, from a patentablity perspective, from any of the other devices referenced in this filing.
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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 symbol that resembles a caduceus, with three abstract human figures or forms intertwined. The symbol is rendered in black and is the focal point of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
Cindy Domecus Vice President, Clinical Research and Regulatory Affairs Kyphon Inc. 1221 Crossman Avenue Sunnyvale, California 94089
Re: K041584
Trade/Device Name: KyphX® HV-R™ Bone Cement, Model C01A Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Codes: NDN Dated: June 11, 2004 Received: June 14, 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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Page 2 -- Ms. Cindy Domecus
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,
Miriam C. Provost
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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Indications for Use
510(k) Number (if known): K041584
Device Name: KyphX® HV-RTM Bone Cement
Indications for Use:
KyphX HV-R bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty procedure. Cancer includes multiple myeloma and metastatic lesions, including those atising from breast or lung cancer, or lymphoma. Benign lesions include hemagioma and giant cell tumor.
Prescription Use X (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)
Page 1 of 1
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_Ko41584
§ 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.”