The Spider System Kolibri Cement Needle 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 needle has the following characteristics:

. entirely cannulated needle;
threaded proximal end to screw the needle into the pedicle to temporarily link the . needle to the pedicle during the cement injection; .
. luer-lock to allow the easy connection with standard syringes and with other system of injection of the cement;
. windows in the distal end that allow the outflow of cement and its optimal distribution around the needle.
The device is supplied in an appropriately labeled sterile packaging.

AI/ML Overview

The provided text is a 510(k) summary for the Sintea Plustek's Spider System KOLIBRI Cement Needle. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a complex diagnostic or therapeutic device might.

Therefore, many of the requested elements regarding acceptance criteria, performance studies, expert involvement, and ground truth are not applicable or not provided in this type of submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Mechanical Testing Requirements	"No mechanical testing is required."	The submission asserts that no mechanical testing is necessary to demonstrate substantial equivalence for this device.
Biocompatibility	"All materials used in fabrication of the Spider System KOLIBRI Cement Needle were evaluated through functional testing and appropriate quality system requirements."	The evaluation of materials is mentioned, but specific acceptance criteria or performance results are not detailed. It likely refers to standard material biocompatibility testing as part of quality systems, rather than a specific performance study in the context of this 510(k).
Sterility	"The device is supplied in an appropriately labeled sterile packaging."	Implies the device meets sterility requirements, but specific acceptance criteria or testing results are not provided.
Substantial Equivalence to Predicate Devices (Key Characteristics)	- Indications for Use: Substantially equivalent	The primary "performance" criterion for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This is met for all listed characteristics.
	- Materials: Substantially equivalent
	- Dimensions: Substantially equivalent
	- Function: Substantially equivalent
Technological Characteristics	"There are no significant differences in technological characteristics compared to the predicate device."	This is a key statement of equivalence.

Study Details

The provided document describes a 510(k) Pre-Market Notification, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device (predicate device). It is not a clinical study or a performance study in the sense of establishing new performance metrics or efficacy. Instead, it relies on demonstrating equivalence through comparison of design, materials, and intended use.

Therefore, the following information is not applicable or not provided in this 510(k) summary:

Sample size used for the test set and the data provenance: Not applicable. No "test set" of patient data or samples was used for a performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from expert review for a performance test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 cement needle, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There was no "ground truth" used in the context of a performance study. The "truth" here is the prior FDA clearance of predicate devices and the demonstration that the new device is sufficiently similar.
The sample size for the training set: Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K130402

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510(k) SUMMARY Sintea Plustek's Spider System KOLIBRI Cement Needle

Date:

January 18, 2012

APR 0 1 2013

Contact:

Guido Zorzoli 305-673-6226 Sintea Plustek 407 Lincoln Road Suite 10/L Miami, FL 33139

Trade Name:	Spider System KOLIBRI Cement Needle
Common Name:	Needle
Product Class:	Class II
Classification:	21 CFR §888.3027
Product Code:	NDN, HXG
Panel Code:	87

Name of Device and Name/Address of Sponsor

Sintea Plustek, LLC 407 Lincoln Road Suite 10/L Miami, FL 33139 305-673-6226

Purpose:

The purpose of this submission is clearance of the Spider System KOLIBRI Cement Needle as an additional component to the Spider System (K072198).

Device Description

The needle has the following characteristics:

. entirely cannulated needle;
threaded proximal end to screw the needle into the pedicle to temporarily link the . needle to the pedicle during the cement injection; .
. luer-lock to allow the easy connection with standard syringes and with other system of injection of the cement;
. windows in the distal end that allow the outflow of cement and its optimal distribution around the needle.

The device is supplied in an appropriately labeled sterile packaging.

Predicate Device

The Spider System KOLIBRI Cement Needle is substantially equivalent to a legally marketed predicate device. The predicate device is the Sintea Spider System (K072198), Cardinal Health AVAflex Vertebral Augmentation Needle (K072133) and the Disc-O-Tech Confidence Bone Cement Needle (K063067).

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Intended Use / Indications for Use

Summary of Testing:

All materials used in fabrication of the Spider System KOLIBRI Cement Needle were evaluated through functional testing and appropriate quality system requirements. No mechanical testing is required.

Summary:

The Spider System KOLIBRI Cement Needle is substantially equivalent to the predicate devices in regards to:

. Indications for Use
. Materials
. Dimensions
. Function

There are no significant differences in technological characteristics compared to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the left side of the eagle.

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

Letter dated: April 1, 2013

Sintea Plustek % Mr. Guido Zorzoli President 407 Lincoln Road, Suite 10/L Miami, Florida 33139

Re: K130402

Trade/Device Name: Spider KOLIBRI Needle Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HXG Dated: March 5, 2013 Received: March 7, 2013

Dear Mr. Zorzoli:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Guido Zorzoli

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement

510(k) Number (if known): _ Device Name: Spider KOLIBRI Needle

Indications for Use:

Prescription Use _ V (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130402

Regulation Number and Section

§ 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.”