BIOSORB ® Resorbable Void Filler is a resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.

BIOSORB ® Resorbable Void Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.

The BIO 1-KIT ® BIOSORB® filled cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with the BIOSORB ® Resorbable Void Filler and deliver the material to the orthopedic surgical site.

Device Description

BIOSORB ® bone void filler (BIO1 range of products) (K021963) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βTCP) indicated for Bone Void Filling.

BIOSORB ® bone void filler presents a multidirectional interconnected porosity structure (45% and 70%), similar to that of the human cancellous bone. BIOSORB ® bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption within 6-12 months prevents premature resorption and failed filling.

The impregnation of bone substitute with marrow is largely practiced by the surgeons. Usually this operation is done by immersion of the bone substitute in a container containing the osseous marrow. In order to facilitate this operation and to limit the contact of the mixture with the ambient air at the origin of the degradation of the cells and proteins contained in osseous marrow, S.B.M has developed a system allowing the and procession of autologous osseous marrow, the impregnation of the calcium phosphate pellets and the impaction of the mixture in the cavity to be filled. This system allows the impregnation of porous pellets with osseous marrow under aseptic conditions.

BIO 1-Kit® comprises :

a pre-filled syringe of BIOSORB® (β-ΤCP porous ceramic pellets)
a connector with an adapter and a needle
a bone marrow aspiration needle

BIO 1-Kit® is delivered sterile and intended for a single use.

BIO 1-Kit® is available either with BIOSORB® granules (1.5 and 3.0 mm in diameter) or BIOSORB® blocks (4x4x4 mm) and in quantities ranging from 5 cc to 45 cc.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the BIO 1-KIT ® BIOSORB® filled cartridge:

Acceptance Criteria and Device Performance for BIO 1-KIT ® BIOSORB® filled cartridge

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting specific quantitative acceptance criteria for the BIO 1-KIT® BIOSORB® filled cartridge itself (the new device being reviewed). Instead, it relies heavily on the established safety and effectiveness of its main component, BIOSORB® bone void filler (which had its own prior 510(k) clearance, K021963), and the substantial equivalence of the new syringe system to a similar predicate.

Therefore, the "acceptance criteria" presented below are inferred from the types of tests performed and the claims made about the device's functionality and safety, especially regarding its new features (the cartridge system).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from tests/claims)	Reported Device Performance
For BIOSORB® (bone void filler component):
Biocompatibility	Excellent biocompatibility; non-toxic, non-allergenic, no inflammation, no adverse systemic effects.
Material Characteristics	Conforms to ASTM F 1088-2004 (Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation).
Osseo-integration & Bone Replacement	Clinical and radiological data demonstrate osseo-integration and replacement by osseous tissues.
Resorption Profile	Progressive resorption within 6-12 months.
For BIO 1-KIT® (cartridge system component):
Material Compatibility (syringe & contents)	Assessed by infra-red spectrometry. Results imply compatibility and absence of particle release.
Aspiration and Impregnation Functionality	Testing performed; implicit successful performance for aspiration of autogenous blood/marrow and impregnation of pellets.
Sterility	Delivered sterile.
Single Use	Intended for single use.
Substantial Equivalence	Substantially equivalent to VITOSS-Filled cartridge K032130 in terms of intended use, material, design, and function.

2. Sample Size Used for the Test Set and Data Provenance

For BIOSORB® (prior clearance K021963):
- Sample Size: A "human clinical trial" was performed. The specific number of subjects/cases is not provided in this 510(k) summary.
- Data Provenance: Not explicitly stated (e.g., country of origin). Since the submitter is French, it's possible this was an international or European trial, but no details are given. The trial was prospective, as it was conducted to investigate safety and effectiveness.
For BIO 1-KIT® cartridge (new clearance K061022):
- Sample Size: Not specified for the "compatibility," "aspiration," and "impregnation" tests. These appear to be bench or lab-based tests, not clinical trials.
- Data Provenance: Not specified beyond being performed by S.B.M. (the manufacturer). Retrospective or prospective is not applicable for these bench tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

For BIOSORB® (prior clearance K021963):
- No information is provided on the number and qualifications of experts involved in establishing ground truth for the clinical trial data discussed. The text refers to "clinical and radiological data" but doesn't detail the expert review process.
For BIO 1-KIT® cartridge (new clearance K061022):
- Not applicable as no clinical ground truth was established for the specific cartridge functionality tests described. These were likely internal engineering or quality control assessments.

4. Adjudication Method for the Test Set

For BIOSORB® (prior clearance K021963): Not described.
For BIO 1-KIT® cartridge (new clearance K061022): Not applicable, as there were no clinical test sets requiring adjudication described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence of a medical device (bone void filler cartridge) for its physical and functional properties, not on AI-assisted diagnostic or therapeutic interpretation by human readers. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant to this device submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm-only performance study was not done. This device is a physical medical product (a cartridge system for bone void filler), not a software algorithm or AI-driven tool.

7. The Type of Ground Truth Used

For BIOSORB® (prior clearance K021963):
- Clinical and Radiological Data: The summary mentions "Clinical and radiological data demonstrate the biocompatibility, the osseo integration and the resorption of BIOSORB® bone void filler." This implies a combination of direct clinical observations (e.g., patient outcomes, inflammatory response) and interpretation of medical imaging (e.g., X-rays to assess bone consolidation and resorption). Pathology results or specific outcome measures (beyond "stable osseous fusion") are not explicitly detailed as the ground truth, but rather general clinical/radiological findings.
For BIO 1-KIT® cartridge (new clearance K061022):
- Bench Test Results/Specifications: The ground truth for tests like "compatibility" (infra-red spectrometry) and "aspiration/impregnation" would be based on predefined physical or chemical specifications and successful functional operation, not clinical ground truth.

8. The Sample Size for the Training Set

Not applicable. This submission describes a physical medical device. There is no mention of an algorithm or machine learning component requiring a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI algorithm is involved.

Summary

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JU(K) Fremarket Notification

BIO 1-KIT ® BIOSORB® filled cartridge

CIENCE FOR ATERIALS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. GENERAL INFORMATION

MAY 2 4 2006

Trade Name	BIO 1-KIT ® BIOSORB® filled cartridge
Common Name	Bone void filler and bone graft delivery syringe
Classification Name	Resorbable Calcium Salt Bone Void Filler device
Class	II
Product Code	MQV
CFR section	21CFR 888.3045
Device panel	Orthopedic
Legally marketed predicate devices	BIOSORB® Resorbable Void Filler K021963 (SBM)VITOSS-Filled cartridge K032130 (Orthovita Inc)
Submitter	SCIENCE FOR BIOMATERIALSSciences et Bio MatériauxZI du MongeF 65100 LOURDES - FRANCEOwner operation Number : 9063735Establishment Registration Number:3004549189
Contact	Denis CLEMENT, General ManagerPhone : +33 (0)5 62 42 21 01Fax : +33 (0)5 62 42 21 00e-mail : denis.clement@sgm-fr.comRegulatory contact: Idée Consulting (FRANCE)Isabelle DRUBAIX e-mail : idrubaix@nordnet.fr

2. DEVICE DESCRIPTION

BIOSORB ® bone void filler (BIO1 range of products) (K021963) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βTCP) indicated for Bone Void Filling.

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I BIOSORB filled

and proteins contained in osseous marrow, S.B.M has developed a system allowing the and procession of autologous osseous marrow, the impregnation of the calcium phosphate pellets and the impaction of the mixture in the cavity to be filled. This system allows the impregnation of porous pellets with osseous marrow under aseptic conditions.

BIO 1-Kit® comprises :

a pre-filled syringe of BIOSORB® (β-ΤCP porous ceramic pellets) A
a connector with an adapter and a needle 公
a bone marrow aspiration needle A

BIO 1-Kit® is delivered sterile and intended for a single use.

BIO 1-Kit® is available either with BIOSORB® granules (1.5 and 3.0 mm in diameter) or BIOSORB® blocks (4x4x4 mm) and in quantities ranging from 5 cc to 45 cc.

3. INTENDED USE

4. PERFORMANCE DATA

BIOSORB® (K021963) conforms to the recognized consensus standard specification ASTM F 1088-2004 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. FDA has recognized the use of this consensus standard as verification of material characteristics and biocompatibility for surgical application (Recognition List Number: 011 Effective Date: 09/01/2004).

Moreover, the biocompatibility of βTCP implants is well documented. As a biomaterial β TCP has consistently proven to be non toxic, non allergenic, biocompatible and elicits no inflammation. No adverse system effects have been reported.

A wide variety of tests (cytotoxicity, sensitization, genotoxicity and mutagenicity, systemic toxicity, irritation, systemic tolerance, Pyrogenicity) was performed on

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BIOSORB® (refer to K021963). Testing performed on BIOSORB" shows an excellent biocompatibility with no significant adverse observations of any kind.

A human clinical trial (K021963) has been performed to investigate the safety and effectiveness of BIOSORB ® bone void filler and more especially the achievement of a stable osseous fusion in consolidation of bone defects, the absence of inflammatory or septic response and the resorption of the BIOSORB® implant and its replacement by osseous tissues. Clinical and radiological data demonstrate the biocompatibility, the osseo integration and the resorption of BIOSORB ® bone void filler.

In addition the following tests were performed on the BIO 1-KIT ® BIOSORB® filled cartridge:

A The compatibility and the absence of particles release from the polypropylene syringe has been assessed by infra-red spectrometry
A Testing of aspiration and impregnation has been performed

5. SUBSTANTIAL EQUIVALENCE

BIO 1-KIT ® BIOSORB® filled cartridge is substantially equivalent to its predicate device VITOSS-Filled cartridge K032130 (Orthovita Inc) in terms of intended use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness.

Summary preparation date: March 31, 2006

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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AS." are arranged in a semi-circle around the left side of the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2006

Science for Bio Materials % Mr. Denis Clement General Manager ZI du Monge F 65100 Lourdes - France

Re: K061022

Trade/Device Name: BIO 1-KIT® BIOSORB® filled cartridge Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 7, 2006 Received: April 24, 2006

Dear Mr. Clement:

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 mav 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

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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. 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 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/industry/support/index.html.

Sincerely yours,

Hebert Leemans

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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Page 3 - Mr. Denis Clement

Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

cc: HFZ-401 DMC

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061022 510(k) Number (if known):

Device Name: BIO 1-KIT ® BIOSORB® filled cartridge

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of General, Restorative,
and Neurological Devices

510(k) Number K061022 000002

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.