(73 days)
Parallax * Acrylic Resin with TRACERS® Ta is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myleoma).
Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone coment.
The provided 510(k) summary for the ArthroCare Corporation Parallax® Acrylic Resin Kit with TRACERS* Ta Bone Cement Opacifier (K050864) does not describe a study involving acceptance criteria, device performance, sample sizes, expert ground truth, or adjudication methods for AI/software-as-a-medical-device (SaMD).
This 510(k) is for a material modification to an existing medical device, Parallax® Acrylic Resin with TRACERS (K042947), which is a polymethylmethacrylate (PMMA) bone cement. The core assertion is that the modification is not a substantial change and does not significantly affect the safety or efficacy of the device.
Therefore, most of the requested information regarding acceptance criteria, study design for performance, comparative effectiveness with AI, and ground truth establishment, which are typical for SaMD or new device clearances, are not applicable to this specific submission.
Here's a breakdown of the relevant (and non-applicable) points based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The provided document does not contain an acceptance criteria table or reported device performance data in the context of a clinical or performance study as it's a material modification filing. The submission argues that the modification in material is "not a substantial change or modification, and does not significantly affect the safety or efficacy of the device" by establishing substantial equivalence to a predicate device (K042947).
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. No explicit "test set" and its sample size are mentioned for a performance study. Clinical data or performance test on a specific sample set to demonstrate efficacy or safety against acceptance criteria is not provided in this 510(k) summary for this type of material modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. No "ground truth" establishment is described, as there's no performance study involving expert review of a test set.
4. Adjudication Method for the Test Set:
- Not Applicable. No adjudication method is described, as there's no performance study involving a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a bone cement material modification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. A standalone algorithm performance study was not done. This device is a physical medical device (bone cement), not a software algorithm.
7. The Type of Ground Truth Used:
- Not Applicable. No ground truth is mentioned, as there's no performance study in the context of this 510(k) summary. The claims are based on substantial equivalence to a predicate device, implying that the established safety and efficacy of the predicate device extend to the modified device due to the minor nature of the modification.
8. The Sample Size for the Training Set:
- Not Applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. There is no mention of a "training set" or its ground truth establishment.
Summary of the 510(k) Filing:
This 510(k) submission (K050864) is a "Special 510(k)" for a "material modification" to an already cleared device, Parallax® Acrylic Resin with TRACERS (K042947). The core argument for clearance is that the modification is not a substantial change and therefore does not significantly affect the safety or efficacy of the device. This type of submission typically relies on comparing the modified device's characteristics (e.g., material properties, biocompatibility) to the predicate rather than presenting new clinical or performance study data with defined acceptance criteria and ground truth. The FDA's letter confirms substantial equivalence to the legally marketed predicate.
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510(k) Summary
ArthroCare Corporation Parallax® Acrylic Resin Kit with TRACERS* Ta Bone Cement Opacifier
General Information
| Submitter Name/Address: | ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-3523 |
|---|---|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-NgDirector, Regulatory Affairs |
| Date Prepared: | April 4, 2005 |
| Device Description | |
| Trade Name: | Parallax ' Acrylic Resin with TRACERS" Ta |
| Classification Name: | Bone Cement (21 CFR 888.3027) |
| Device Classification: | Class IIPanel: Orthopedic Devices |
Predicate Devices
Parallax® Acrylic Resin with TRACERS* K042947
Product Description
Parallax Acrylic Resin with TRACERS Ta is an opacified polymethylmethacrylate (PMMA) bone coment.
Intended Uses
Parallax Acrylic Resin with TRACERS Ta is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myleoma).
N
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Substantial Equivalence
Substantial Equivalence
This Special 510(k) proposes a material modification for the Parallax Acrylic Resin with This Special 510(k) proposes a materard in K042947 on December 27, 2004. The TKACERS, which was previously endaled in the secure and sterilization mulcations for use, technology princesses with TRACERS remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
Summal y of Safety and Enectricals:3
The modified Parallax Acrylic Resin with TRACERS, as described in this Special 510(k), The modified I aranax Neryne Researce device. The proposed modification in material is not a substantial change or modification, and docs not significantly affect the safety or efficacy of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 resembling three overlapping human figures or waves, creating a sense of movement and connection.
Public Health Service
JUN 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-3523
Re: K050864
Trade/Device Name: Parallax® Acrylic Resin with TRACERS® TA Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN,LOD Dated: April 4, 2005 Received: April 5, 2005
Dear Ms. Defiesta-Ng:
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. Valerie Defiesta-Ng
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
Acting 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): K 250 86 4
Device Name: Parallax " Acrylic Resin with TRACERS" Ta
Indications for Usc:
Parallax * Acrylic Resin with TRACERS® Ta is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myleoma).
Prescription Use X Over-the-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) . .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hupd Rlurlio
(Division Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.”