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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Sintea Biotech Spider Spinal System. It does not describe a study that proves the device meets acceptance criteria, nor does it provide a table of acceptance criteria and reported device performance. The document focuses on regulatory submission for market clearance rather than detailed performance study results against specific criteria.

Therefore, most of the requested information cannot be extracted from this document because it outlines a regulatory submission rather than a clinical or performance study.

Here's what can be gathered based on the available text:

General Information from the Document:

Device Name: SPIDER™ Spinal System
Intended Use: 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.

Given that the document does not contain a detailed study proving the device meets acceptance criteria, the following points will be answered based on the absence of information in the provided text.

Acceptance Criteria and Device Performance:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Information not provided. The document states "There is no set standard of testing for this type of device."
- Reported Device Performance: Information not explicitly detailed in quantifiable acceptance criteria format. The document generically states that "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." However, Section 18 is not included in the provided text.

Study Details (Based on absence of information):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable as no performance study details are provided in this summary. The document mentions "mechanical tests" but does not detail their methodology, sample size, or data provenance.
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):
- Not applicable. No ground truth for a test set is discussed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set adjudication is discussed.
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:
- Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth for a study is discussed. The "performance data" mentioned refers to mechanical tests validating engineering specifications, not clinical outcomes or diagnostic accuracy against a ground truth.
The sample size for the training set:
- Not applicable. No training set for an algorithm is mentioned.
How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.

Summary

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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 888.454021 CFR 888.4200
	Regulation Name:	Orthopedic manual surgical instrument.Cement dispenser.
	Product Code:Secondary Product Code:	HXGOAR

III. Product Description

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.

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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:

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

Regulation Number and Section

§ 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.