(304 days)
Not Found
No
The summary describes a mechanical device for creating a cavity in bone and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to create a cavity in bone to treat "pathological compression fractures" which indicates a therapeutic purpose.
No
The device is described as a system for creating a cavity in cancellous bone and compressing bone, indicating it is an interventional or therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like Nitinol, indicating it is a hardware device, not software-only.
Based on the provided information, the SPIDER™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "creation of a cavity in cancellous bone in the spine" to treat fractures. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a mechanical device (expandable tamp, gauge, awl, wires, reamer) designed for physical manipulation of bone tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples for diagnostic purposes. The SPIDER™ is a surgical instrument used directly on the patient's bone.
N/A
Intended Use / Indications for Use
The SPIDER™ is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HXG, OAR, HRX
Device Description
The Sintea Biotech's SPIDER™ expandable tamp is designed to compress cancellous bone as it expands. The SPIDER™ consist of a controlled expanding tamp at the distal end, a cannulated gauge, an awl, guided wires, and a reamer. The product has the same intended use as the predicate. The expandable tamp is made out of biocompatible Nitinol metal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cancellous bone in the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
There is no set standard of testing for this type of device. Sintea Biotech has performed mechanical tests to verify the device meets the functional and performance specifications it was designed for.
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.
Not Found
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
072198
JUN - 6 2008
Spider Spinal System 510(k) Summary
- I. Sintea Biotech, Inc. Company: 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 (305) 673-6226
| II. | Proprietary Trade Name: | Xvoid™
SPIDER™ |
|-----|------------------------------------------|-------------------------------------------------------------|
| | Regulation Number: | 21 CFR 888.4540
21 CFR 888.4200 |
| | Regulation Name: | Orthopedic manual surgical instrument.
Cement dispenser. |
| | Product Code:
Secondary Product Code: | HXG
OAR |
III. Product Description
The Sintea Biotech's SPIDER™ expandable tamp is designed to compress cancellous bone as it expands. The SPIDER™ consist of a controlled expanding tamp at the distal end, a cannulated gauge, an awl, guided wires, and a reamer. The product has the same intended use as the predicate. The expandable tamp is made out of biocompatible Nitinol metal.
IV. Indications
The SPIDER 110 is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.
V. Performance Data
There is no set standard of testing for this type of device. Sintea Biotech has performed mechanical tests to verify the device meets the functional and performance specifications it was designed for. Please see section 18 of this 510(k) submission for detailed test and results.
1
VI. Substantial Equivalence
The SPIDER™ expandable bone tamps are substantially equivalent to currently marketed bone tamps with regards to intended use, function and performance, in particular with the Kyphx® from Kyphon, Inc., K041454
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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sintea Biotech, Inc. % Mr. Gustavo A. Rios 407 Lincoln Rd, Suite 10L Miami Beach, Florida 33139
JUN - 6 2008
Re: K072198
Trade/Device Name: Spider™ System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, HXG, OAR Dated: May 12, 2008 Received: May 28, 2008
Dear Mr. Rios:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Gustavo Rios
This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mullison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072198
Device Name: SPIDERIA
Indications for Use:
The SPIDER™ is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Neil R. Posh for mrm
Division of General, Restorative, and Neurological Devices
510(k) Number K072198