(313 days)
No
The summary describes a mechanical device (a balloon tamp) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is used for mechanical manipulation of bone to create a void, rather than directly treating a medical condition or restoring function.
No
The device is described as a surgical tool (bone tamp) used for fracture reduction and creating voids in bone, not for diagnosing conditions.
No
The device description clearly details a physical, inflatable bone tamp with a catheter shaft, lumens, and a wire mandrel, indicating it is a hardware device, not software-only.
Based on the provided information, the NeuroTherm Parallax Balloon Inflatable Bone Tamp is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for a surgical procedure (reducing and fixing fractures, creating voids in bone). IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical device with an inflatable component designed to interact directly with bone tissue within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD testing.
Therefore, the NeuroTherm Parallax Balloon Inflatable Bone Tamp is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Product codes
HRX, HXG, NDN
Device Description
The NeuroTherm Parallax Balloon Inflatable Bone Tamp with an inflatable component at the distal end. The tamp is designed to compress cancellous bone and/or move cortical bone as it inflates. The catheter shaft contains an outer lumen for the tamp inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows for a uniform balloon that is concentric to the catheter shaft. The wire mandrel provides stiffness to the balloon catheter to facilitate insertion through the access cannula. The NeuroTherm Parallax Balloon Inflatable Bone Tamp may be used with FDA cleared balloon inflation syringes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
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
Bench - Bench testing supports that the NeuroTherm Parallax Balloon Inflatable Bone Tamp performs as expected.
Key Metrics
Not Found
Predicate Device(s)
Kyphon Xpander II Inflatable Bone Tamp K101864, KyphX Inflatable Bone Tamp K010246, KyphX Xpander Inflatable Bone Tamp K041454
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Traditional 510(k) Summary
JUN 2 5 2013
A) SUBMITTED BY: NeuroTherm, Inc. 30 Upton Drive, Suite 2 Wilmington, MA 01887-1083 Registration # 1226344
CONTACT: F. David Rothkopf MEDIcept Inc. 200 Homer Ave Ashland. MA 01721 617-899-3449 Phone 508-231-8861 Fax
B) DEVICE NAME: NeuroTherm Parallax Balloon Inflatable Bone Tamp
COMMON NAME: Arthroscope, Tamp
DEVICE CLASS/: 21 CFR 888.1100 Class II Arthroscope, product code HRX PRODUCT CODE 21 CFR 888.4540 Class I Orthopedic manual surgical instrument, product code HXG (Tamp) Accessory to 21 CFR 888.3027, Cement/Bone Vertebroplasty, product code NDN
C) PREDICATES:
- . Kyphon Xpander II Inflatable Bone Tamp K101864
- KyphX Inflatable Bone Tamp . K010246
- . KyphX Xpander Inflatable Bone Tamp K041454
D) DEVICE DESCRIPTION:
The NeuroTherm Parallax Balloon Inflatable Bone Tamp with an inflatable component at the distal end. The tamp is designed to compress cancellous bone and/or move cortical bone as it inflates. The catheter shaft contains an outer lumen for the tamp inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows for a uniform balloon that is concentric to the catheter shaft. The wire mandrel provides stiffness to the balloon catheter to facilitate insertion through the access cannula. The NeuroTherm Parallax Balloon Inflatable Bone Tamp may be used with FDA cleared balloon inflation syringes.
1
E) INTENDED USE/INDICATIONS FOR USE:
The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
2
K122503 page 3/4
SUBSTANTIAL EQUIVALENCE COMPARISON AND DISCUSSION E)
. . . . . .
| Product codes | NeuroTherm Parallax Balloon Inflatable
Bone Tamp | KyphX Xpander
Bone Tamp | KyphX Inflatable
Bone Tamp |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | HRX, HXG
Accessory to NDN | K101864/K041454
HRX, HXG | K010246
HRX |
| Intended Use
Indication for Use | The NeuroTherm Parallax Balloon
Inflatable Bone Tamp is intended to be used
as a conventional bone tamp for the
reduction and fixation of fractures and/or
creation of a void in cancellous bone in the
spine. This includes use during
percutaneous vertebral augmentation. The
Parallax Balloon Inflatable Bone Tamp is to
be used with cleared spinal
polymethylmethacrylate (PMMA) bone
cement indicated for use during
percutaneous vertebral augmentation, such
as kyphoplasty. | The KYPHON Xpander is
intended to be used as a
conventional bone tamp for the
reduction of fractures and/or
creation of a void in cancellous
bone in the spine (including use
during balloon kyphoplasty with a
PMMA-based bone cement that is
cleared for use in kyphoplasty
procedures) hand, tibia, radius and
calcaneus. | 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. |
| Description | | | |
| Tamp | Inflatable bone tamp consisting of a double lumen catheter shaft constructed from two coaxially aligned tubings | | |
| Side adaptor | A side arm adapter provides access to the catheter lumens allowing inflation and deflation | | |
| Straight arm port | A continuous straight arm port in inner catheter lumen allows placement of a non-removable stiffening stylet which
attaches to the Luer fitting of the straight arm | | |
| Markers | Radiopaque markers for balloon visualization | Exit marker band | |
| Balloon length
indicator | Yes
Printed band | Yes
Color coded band | Unknown |
| Sterilization | EtO | Gamma irradiation | |
.
4-3
3
(F) CONCLUSION
The NeuroTherm Parallax Balloon Inflatable Bone Tamp is similar to or the same as the predicate devices for use as follows:
- Technology .
- . Intended use/Indication for Use in the spine
- Technical specifications or range of technical specifications .
Any differences between the NeuroTherm Parallax Balloon Inflatable Bone Tamp and the predicate devices do not raise new issues of safety or effectiveness. Therefore, the NeuroTherm Parallax Balloon Inflatable Bone Tamp is substantially equivalent to the predicate devices.
G) PERFORMANCE TESTING
There are no applicable performance Consensus Standards or Guidance documents associated with this device.
Bench - Bench testing supports that the NeuroTherm Parallax Balloon Inflatable Bone Tamp performs as expected.
H) COMPLIANCE WITH STANDARDS
- ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of . Orthopedic Implants and Instruments (pub date 10/04/2010)
- ANSI/AAMI/ISO 11135:2007 Sterilization of health care products Ethylene oxide -. Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical device sterilization for EtO sterilized devices i
- ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other ● medical equipment - Part 1: General requirements
- ISO 594-2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other . medical equipment - Part 2: Lock fittings
- ISO 10555-1 First edition 1995-06-5 AMENDMENT 2 2004-05-15 Sterile, single-use . intravascular catheters - Part 1: General requirements
- ISO 10555-2: 1996 Sterile, single-use intravascular catheters -- Part 2: Angiographic . catheters
- ISO 10555-3:1996/ Corrigendum 1:2002 Sterile, single-use intravascular catheters Part . 3: Central venous catheters
- . ISO 10555-4: 1996 Sterile, single-use intravascular catheters -- Part 4: Balloon dilatation catheters
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2013
NeuroTherm, Incorporated % MEDIcept, Incorporated Mr. F. David Rothkopf 200 Homer Avenue Ashland, Massachusetts 01721
Re: K122503
Trade/Device Name: NeuroTherm Parallax Balloon Inflatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN. HRX Dated: May 13, 2013 Received: May 15, 2013
Dear Mr. Rothkopf:
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 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 (reporting of medical
5
Page 2 - Mr. F. David Rothkopf
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin J. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): K122503
Device Name: NeuroTherm Parallax Balloon Inflatable Bone Tamp
Indication for Use:
The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Prescription Use X 21CFR 801, Subpart D OR Over-the-Counter Use 21CFR 801.109
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -A
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122503