(38 days)
KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.
The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801.
The provided document is a 510(k) premarket notification summary for a medical device called the "KyphX® Inflatable Bone Tamps." This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process does not typically involve the elaborate clinical study designs and performance criteria associated with new drug applications or high-risk medical devices that require extensive clinical trials to establish efficacy and safety from scratch.
Therefore, the requested information regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, or standalone algorithm performance cannot be fully extracted from this document because the 510(k) pathway primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data against a set of predefined acceptance criteria in the same way a new, unproven technology would.
Here's an analysis based on the information provided, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance:
This document does not present a table of acceptance criteria and reported device performance in the sense of a clinical trial or a study proving a new device's efficacy against specific benchmarks. The 510(k) process focuses on demonstrating substantial equivalence to predicate devices. This means that if the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed predicate device, it can be cleared for market. The "performance" here is implied to be similar to the predicates.
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 does not mention any specific test set sample sizes or data provenance because it's not a report of a new clinical study with a test set. The substantial equivalence is based on the device's design, materials, and intended use being similar to existing cleared devices.
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):
No information is available regarding experts or ground truth establishment because this document is a regulatory submission for substantial equivalence, not a clinical study report.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information is available regarding adjudication methods.
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 device (KyphX® Inflatable Bone Tamps) is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This device is a physical medical instrument. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as it applies to diagnostic or prognostic algorithms is not applicable to this device. The substantial equivalence argument relies on the device's design, materials, and intended function matching those of predicate devices that have already been cleared for safety and effectiveness.
8. The sample size for the training set:
There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
Summary from the Document:
- Device Name: KyphX® Inflatable Bone Tamps
- Intended Use: "KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus."
- Predicate Devices:
- Basis for Equivalence: "The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801." (K033801 refers to Kyphon's cleared KyphX® HV-R™ Bone Cement, indicating that the overall procedure's safety and effectiveness were considered in a prior submission, and this device is equivalent to the tamp component of that system).
Conclusion:
This 510(k) submission demonstrates substantial equivalence by showing that the KyphX® Inflatable Bone Tamps have the "same technological characteristics and intended use" as already legally marketed predicate devices. It does not contain the detailed clinical study data, acceptance criteria tables, or AI-specific performance metrics that would be found in a Premarket Approval (PMA) application or a study for a novel diagnostic algorithm. The "study" proving the device meets criteria is essentially the FDA's review determining that it is substantially equivalent to previously cleared devices based on its design, materials, and intended use.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2005
Ms. Cindy Domecus Vice President Clinical Research and Regulatory Affairs Kyphon Inc. 1221 Crossman Avenue Sunnyvale, California 94089
Re: K041454
Trade/Device Name: KyphX® Inflatable Bone Tamps Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 28, 2004 Received: June 1, 2004
Dear Ms. Domecus:
This letter corrects our substantially equivalent letter of July 9, 2004.
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 (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 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 continue 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/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkersen
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
Ko41454 510(k) Number (if known):
Device Name: KyphX® Inflatable Bone Tamps
Indications for Use:
KyphX Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.
· 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)
(Division Sign-Of Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_ Koyluky
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Kyphon Inc. Page 1 of 1, Summary KyphX Inflatable Bone Tamps Premarket Notification [510(k)] Submission
Premarket Notification [510(k)] Summary
| May 28, 2004 | JUL 09 2004 |
|---|---|
| Trade Name: | Kyphx® Inflatable Bone Tamps |
| Common Name: | Inflatable Bone Tamp |
| Classification Name: | Tamp (per 21 CFR section 888.4540) and Arthroscope (per 21 CFR section 888.1100) |
| Manufacturer's Name:Address: | Kyphon Inc.1221 Crossman AvenueSunnyvale, CA 94089(408) 548-6500 |
| Contact Person: | Cindy DomecusVice President, Clinical Research & Regulatory Affairs |
| Predicate Device(s): | KyphX® Directional Inflatable Bone Tamp, K032212KyphX® Inflatable Bone Tamp, K010246Kyphon Inflatable Bone Tamp, K981251 |
| Device Description: | The KyphX® Inflatable Bone Tamps are the identified predicate devices. They are bone tamps with an inflatable component at the distal end. The products have the same technological characteristics and intended use as described for the predicates. Safety and effectiveness for use in kyphoplasty procedures is described in K033801. |
| Indication for Use: | KyphX® Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus. |
As with Kyphon's cleared Kyphx® inflatable Bone Tamp 510(k)s, K981251, K102046, and K03212, and Kyphon's cleared KyphX® HV-R™ Bone Cement 510(k), K033801, any statement regarding "substantial marketed without premarket approval or reclassification, and is not interpreted as an admission or any other type of evidence in any patent proceeding, including patent litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent or patent application, 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.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.