(181 days)
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
This document is a 510(k) Summary for a medical device (Stryker® iVAS Balloon Catheter), which typically demonstrates substantial equivalence to a predicate device rather than presenting a de novo clinical study with strict acceptance criteria for a novel AI algorithm. Therefore, many of the requested fields regarding AI algorithm performance, training sets, and expert adjudication are not applicable or not explicitly detailed in the provided text.
Based on the provided text, here's the information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a medical device, the "acceptance criteria" are not framed as specific performance metrics of an AI model, but rather as meeting established engineering and biocompatibility standards to demonstrate substantial equivalence to predicate devices. The performance is reported as meeting these standards.
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Functional & Performance Testing | "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. The testing which was conducted included functional testing, such as insertion and retraction force, force to puncture, burst and simulated use." |
| Biocompatibility | "Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible." |
| Substantial Equivalence (General) | "The Stryker® iVAS balloon catheter is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Stryker® iVAS Balloon Catheter and the Kyphx Xpander Inflatable Bone Tamp. The products have the same fundamental scientific technology, basic design, functional characteristics and the same clinical applications." |
| Safety and Effectiveness (General) | "The Stryker® iVAS balloon catheter does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed. Therefore, the Stryker® iVAS balloon catheter is equivalent to the existing predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes engineering tests (functional, performance, biocompatibility) rather than a clinical human-subject test set. Therefore, "sample size" in a clinical sense and "data provenance" (country/retrospective/prospective) are not applicable or mentioned. The testing seems to involve physical devices or materials.
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. This is not a study requiring expert ground truth for clinical image analysis or similar tasks. The "ground truth" for engineering tests would be the established performance specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective clinical assessments, which are not described here.
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 document does not describe an AI medical device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For functional and performance testing, the "ground truth" would be the engineering specifications and established test methods, which the device's performance was compared against.
For biocompatibility, the "ground truth" refers to the requirements set forth in the FDA Blue Book Memorandum G95-1 (ISO-10993).
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI training set involved.
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4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 ff: 269 324 5412
www.stryker.com
JUN 2 8 2011
stryker
్రామ్నా
Instruments
| 510(k) Summary | |
|---|---|
| 510(k) Owner: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
| Contact Person: | Melissa Kann |
| Registration No.: | 1811755 |
| Trade Name: | Stryker® iVAS Balloon Catheter |
| Common Name: | Inflatable Bone Tamp |
| Classification Name: | ArthroscopeCement, Bone, Vertebroplasty |
| Regulation Number: | §888.1100§888.3027 |
| Product Code: | HRXNDN |
| Predicate Device: | Stryker® iVAS Balloon Catheter (K093419)Kyphx Xpander Inflatable Bone Tamps (K041454) |
| Device Description: | The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component(balloon) at the distal end. The balloon is inflated to create a void within thevertebral body. |
| Indications for Use: | The Stryker® iVAS Inflatable Vertebral Augmentation System (system) isintended to be used for the reduction of fractures and/or creation of a void incancellous bone in the spine. This includes use during percutaneous vertebralaugmentation. The system is to be used with cleared spinalPolymethylmethacrylate (PMMA) bone cements indicated for use duringpercutaneous vertebral augmentation procedures, such as kyphoplasty |
| Testing: | The Stryker® iVAS balloon catheter meets the specification and performancecharacteristics and are substantially equivalent to the predicate devices. Thetesting which was conducted included functional testing, such as insertion andretraction force, force to puncture, burst and simulated use. |
| Biocompatibility: | Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that thedevice meets the applicable requirements of the FDA Blue Book MemorandumG95-1 entitled Use of International Standards ISO-10993 Biological Evaluation ofMedical Devices Part -1: Evaluation and Testing and are biocompatible. |
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '103807'. The numbers are written in a simple, clear style, and the image appears to be a close-up of the sequence.
Image /page/1/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and the letter "y" has a long, curved tail. There is a registered trademark symbol to the right of the letter "r". The word is likely a logo or brand name.
Instruments
Substantial Equivalence (SE) Rational:
The Stryker® IVAS balloon catheter is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Stryker® iVAS Balloon Catheter and the Kyphx Xpander Inflatable Bone Tamp. The products have the same fundamental scientific technology, basic design, functional characteristics and the same clinical applications.
Safety and Effectiveness:
The Stryker® iVAS balloon catheter does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed. Therefore, the Stryker® iVAS balloon catheter is equivalent to the existing predicate devices.
Submitted by:
Melissa Kann Regulatory Affairs Supervisor
10-June-2011
eussa kanu
Signature
Signature
Date Submitted:
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Corporation % Ms. Melissa Kann Regulatory Affairs Supervisor 4100 E. Milham Ave Kalamazoo, Michigan 49001
JUN 2 8 2011
Re: K103807
Trade Name: iVAS 2-10mm (10 Gauge) Balloon Catheter Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: June 06, 2011 Received: June 08, 2011
Dear Ms. Kann:
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
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Page 2 - Ms. Melissa Kann
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
E.L. Keith
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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510(K) Number (if known):
Device Name: Stryker Inflatable Vertebral Augmentation System (iVAS)
Indications for Use
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
Prescription Use _ X _________________________________________________________________________________________________________________________________________________________
and/or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103807
§ 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.”