(87 days)
Not Found
GSI Surgical Dissector, Koros Microdiscectomy Currette
No
The device description and performance studies focus on mechanical properties and physical function, with no mention of AI or ML.
Yes
Explanation: The device is intended for the reduction of fractures and/or creation of a void in cancellous bone, which are therapeutic actions aimed at treating a medical condition.
No
The device description clearly states its purpose is for "the reduction for fractures and/or creation of a void in cancellous bone," which is a therapeutic/surgical intervention, not a diagnostic one.
No
The device description clearly details a physical, inflatable bone tamp with a catheter shaft, radiopaque markers, and a side arm adapter for inflation/deflation. This is a 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 is for the reduction of fractures and/or creation of a void in cancellous bone. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical tool (bone tamp) used for mechanical manipulation of bone tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Kyphon Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction for fractures and/or creation of a void in cancellous bone.
Product codes
HRX
Device Description
The Kyphon Inflatable Bone Tamp is a bone tamp with an inflatable component at the distal end. It is designed to compress cancellous bone and/or move cortical bone as it inflates. The Inflatable Bone Tamp has a nominal length of 40 cm and consists of a double lumen catheter shaft constructed from two coaxially aligned tubings. The inflatable component is mounted near the distal tip of the catheter tubing. Two radiopaque marker bands are attached to the inner tubing and located at the proximal and distal ends of the inflatable component.
A side arm adapter attached to the proximal end of the Inflatable Bone Tamp provides access to the catheter lumens. Inflation and deflation are accomplished by connecting the side arm port with an inflation syringe. The straight arm port is continuous with the inner lumen of the catheter to allow placement of a removable stiffening stylet, which attaches to the Luer fitting of the straight arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cancellous bone, cortical bone (vertebral bodies, tibial plateaus)
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)
Mechanical tests performed for the Inflatable Bone Tamp to verify the device meets specifications and intended performance characteristics include:
Maximum Inflation Volume
Inflated Length
Inflated Diameter
Fatigue Performance
Maximum Recommended Inflation Pressure
Overall Length
Working Length
Shaft Diameter
Inflation Time
Deflation Time
Tamp Insertion Force
Tamp Withdrawal Force
Bond Strength - Outer Tubing to Side Arm
Bond Strength - Inner Tubing to Luer
Bond Strength - Luer to Y-Adapter
Biocompatibility Testing
Results from all tests demonstrated the Inflatable Bone Tamp performed according to design specifications.
Pre-clinical testing was conducted to verify that the Kyphon Inflatable Bone Tamp performs according to its design specification and to validate substantial equivalence to the performance of conventional bone tamps. Tests of intended use, performance to specification and safety were conducted in isolated, fractured, cadaveric vertebral bodies. Tests of percutaneous deployment and intended use were performed in fractured tibial plateaus in cadaver knees and in unfractured vertebral bodies in cadaver spines.
The results of these tests demonstrated that Kyphon Inflatable Bone Tamps can reduce fractures, and create voids in cancellous bone, in the same manner and with the same results as predicate conventional bone tamps. These tests also showed product performance in bone conformed to design specifications. Safety testing demonstrated that the risks of tamping with Inflatable Bone Tamps are the same as those of conventional bone tamps, and that the risks of product failure are the same as those of inflatable dissectors and other inflatable medial products.
Kyphon Inc. has determined, based on these tests, that the device conforms to its specifications and is at least as safe and effective as the predicate devices for tamping cancellous bone and/or elevating cortical bone.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
GSI Surgical Dissector (Class II), Koros Microdiscectomy Currette (Class II)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol that appears to be three human profiles facing to the right, stacked on top of each other.
SEP 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy Domecus Vice President Clinical Research and Regulatory Affairs Kyphon Inc. 1221 Crossman Avenue Sunnyvale, California 94089
Re: K981251
Trade/Device Name: Kyphon Inflatable Bone Tamp Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: April 3, 1998 Received: April 6, 1998
Dear Ms. Domecus:
This letter corrects our substantially equivalent letter of July 2, 1998, regarding the regulation number for your device.
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.
1
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 N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510{k} Number (if known): K981251
Device Name: Kyphon Inflatable Bone Tamp
Indications For Use:
Kyphon Inflatable Bone Tamps are intended to be used as conventional bone tamps for the reduction for fractures and/or creation of a void in cancellous bone.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) K981251
(Division Sign-O
Division of General Restorative Devices K9 8125/
510(k) Number
Prescription Use X
(Per 21 CFR 801.109)
..
OR
Over-The-Counter Use
(Optional Formas 1-2-90)
3
JUL - 2 1998
981251
510(k) Summary of Safety and Effectiveness Kyphon Inflatable Bone Tamp
This 510(k) safety and effectiveness summary is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 and 21 CFR §807.92.
General Information
| Manufacturer: | Kyphon Inc.
3110 Coronado Dr.
Santa Clara, CA 95054 |
|-----------------|-----------------------------------------------------------|
| Contact Person: | Karen Talmadge, Ph.D.
President |
| Date Prepared: | 29 June 1998 |
Device Information
| Classification: | Class II |
|---|---|
| Trade Name: | Kyphon Inflatable Bone Tamp |
| Common Name: | Tamp |
Intended Use
Kyphon 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.
Product Description
The Kyphon Inflatable Bone Tamp is a bone tamp with an inflatable component at the distal end. It is designed to compress cancellous bone and/or move cortical bone as it inflates. The Inflatable Bone Tamp has a nominal length of 40 cm and consists of a double lumen catheter shaft constructed from two coaxially aligned tubings. The inflatable component is mounted near the distal tip of the catheter tubing. Two radiopaque marker bands are attached to the inner tubing and located at the proximal and distal ends of the inflatable component.
A side arm adapter attached to the proximal end of the Inflatable Bone Tamp provides access to the catheter lumens. Inflation and deflation are accomplished by connecting the side arm port with an inflation syringe. The straight arm port is continuous with the inner lumen of the catheter to allow placement of a removable stiffening stylet, which attaches to the Luer fitting of the straight arm.
4
Substantial Equivalence
The Kyphon Inflatable Bone Tamp is substantially equivalent to currently marketed bone tamps, elevators and curettes (Class I) with regard to intended use, function and biomechanical performance. With regard to technological characteristics such as materials, construction and mode of performance (inflatable component), the Inflatable Bone Tamp is substantially equivalent to inflatable dissectors, such as the GSI Surgical Dissector (Class II). For percutaneous use, the Inflatable Bone Tamp is substantially equivalent to endoscopic devices, such as the Koros Microdiscectomy Currette (Class II).
Biocompatibility Evaluations
The materials used in the construction of the Kyphon Inflatable Bone Tamp meet the requirements for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact" as described in the FDA Blue Book Memorandum #G95-1 entitled, "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The biocompatibility tests demonstrate that this device is biocompatible.
Sterilization
The Kyphon Inflatable Bone Tamp is sterilized using ethylene oxide (EtO) and meets the requirements of ANSI/AAMI/ISO11135:1994 for EtO sterilized devices.
Mechanical and Pre-Clinical Tests Performed
Mechanical tests performed for the Inflatable Bone Tamp to verify the device meets specifications and intended performance characteristics include:
Maximum Inflation Volume Inflated Length Inflated Diameter Fatigue Performance Maximum Recommended Inflation Pressure Overall Length Working Length Shaft Diameter Inflation Time Deflation Time Tamp Insertion Force Tamp Withdrawal Force Bond Strength - Outer Tubing to Side Arm Bond Strength - Inner Tubing to Luer Bond Strength - Luer to Y-Adapter Biocompatibility Testing
5
Results from all tests demonstrated the Inflatable Bone Tamp performed according to design specifications.
Pre-clinical testing was conducted to verify that the Kyphon Inflatable Bone Tamp performs according to its design specification and to validate substantial equivalence to the performance of conventional bone tamps. Tests of intended use, performance to specification and safety were conducted in isolated, fractured, cadaveric vertebral bodies. Tests of percutaneous deployment and intended use were performed in fractured tibial plateaus in cadaver knees and in unfractured vertebral bodies in cadaver spines.
The results of these tests demonstrated that Kyphon Inflatable Bone Tamps can reduce fractures, and create voids in cancellous bone, in the same manner and with the same results as predicate conventional bone tamps. These tests also showed product performance in bone conformed to design specifications. Safety testing demonstrated that the risks of tamping with Inflatable Bone Tamps are the same as those of conventional bone tamps, and that the risks of product failure are the same as those of inflatable dissectors and other inflatable medial products.
Kyphon Inc. has determined, based on these tests, that the device conforms to its specifications and is at least as safe and effective as the predicate devices for tamping cancellous bone and/or elevating cortical bone.
Summary
In summary, the Kyphon Inflatable Bone Tamp meets design specifications and performs like conventional bone tamps, elevators and curettes for the reduction of fractures and creation of voids in cancellous bone. The Inflatable Bone Tamp is constructed from similar materials as surgical dissectors and performs using hand pressure (via hydraulic inflation). Design features similar to those in other endoscopic products allow the Kyphon Inflatable Bone Tamp to be used percutaneously. The Kyphon Inflatable Bone Tamp does not raise any new questions of safety or effectiveness.
K
Karen Talmadge, Ph.D.
Karen Talmadge, Ph.D. President Kyphon Inc. 29 June 1998