(38 days)
No
The summary describes a mechanical bone tamp and makes no mention of AI or ML technology.
Yes.
The device is used for the reduction of fractures and creation of a void in bone, which are therapeutic interventions.
No
The device is a bone tamp used for fracture reduction and void creation in cancellous bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "bone tamp with an inflatable component at the distal end," indicating a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical tool used for reducing fractures and creating voids in bone. This is a direct intervention on the patient's body.
- Device Description: The description confirms it's a bone tamp with an inflatable component, used in procedures like kyphoplasty. This is a physical device used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
IVD devices are used in vitro (outside the body) to examine specimens from the body. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine (including use during balloon kyphoplasty with KyphX® HV-R™ Bone Cement), hand, tibia, radius and calcaneus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Avenue | |
| Sunnyvale, CA 94089 | |
| (408) 548-6500 | |
| Contact Person: | Cindy Domecus |
| Vice President, Clinical Research & Regulatory Affairs | |
| Predicate Device(s): | KyphX® Directional Inflatable Bone Tamp, K032212 |
| KyphX® Inflatable Bone Tamp, K010246 | |
| Kyphon 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.