(41 days)
No
The summary describes a bone void filler and a system for mixing it with autologous blood/marrow. There is no mention of any computational analysis, image processing, or data-driven algorithms that would suggest the use of AI/ML. The focus is on the material properties and the delivery system.
Yes.
The device is intended to fill bony voids or gaps of the skeletal system caused by trauma or surgery, to assist in the healing process of bone defects.
No
Explanation: This device, BIOSORB® Resorbable Void Filler, is a bone void filler intended to treat bony voids or gaps. It is used to fill and support bone healing, not to diagnose a condition.
No
The device description clearly outlines physical components (syringe, connector, needle, ceramic pellets) and their intended use in a surgical procedure, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a "resorbable calcium salt bone void filler intended to fill bony voids or gaps of the skeletal system... caused by trauma or surgery". It is used in vivo (within the body) to support bone healing.
- Device Description: The description details a "macroporous implant made of synthetic beta tri Calcium Phosphate (βTCP)" that is "indicated for Bone Void Filling". It also describes a system for mixing the material with autologous blood or bone marrow and delivering it to a surgical site. These are all characteristics of an implantable medical device used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the BIOSORB ® Resorbable Void Filler and the BIO 1-KIT ® are classified as medical devices used for surgical implantation and bone repair, not as In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
BIOSORB (R) 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 (R) 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 (R) BIOSORB(R) 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 (R) Resorbable Void Filler and deliver the material to the orthopedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
BIOSORB bone void filler (BIO1 range of products) (K021963) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (beta TCP) 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(R) (beta-TCP 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(R) granules (1.5 and 3.0 mm in diameter) or BIOSORB(R) blocks (4x4x4 mm) and in quantities ranging from 5 cc to 45 cc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities, spine and pelvis,)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
BIOSORB(R) (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 beta TCP implants is well documented. As a biomaterial beta 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 BIOSORB(R) (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 (R) 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(R) implant and its replacement by osseous tissues. Clinical and radiological data demonstrate the biocompatibility, the osseo integration and the resorption of BIOSORB (R) bone void filler.
In addition the following tests were performed on the BIO 1-KIT (R) BIOSORB(R) filled cartridge:
The compatibility and the absence of particles release from the polypropylene syringe has been assessed by infra-red spectrometry
Testing of aspiration and impregnation has been performed
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.
VITOSS-Filled cartridge K032130 (Orthovita Inc)
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.
BIOSORB® Resorbable Void Filler K021963 (SBM)
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
§ 888.3045 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.
0
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 BIOMATERIALS |
| Sciences et Bio Matériaux | |
| ZI du Monge | |
| F 65100 LOURDES - FRANCE | |
| Owner operation Number : 9063735 | |
| Establishment Registration Number:3004549189 | |
| Contact | Denis CLEMENT, General Manager |
| Phone : +33 (0)5 62 42 21 01 | |
| Fax : +33 (0)5 62 42 21 00 | |
| e-mail : denis.clement@sgm-fr.com | |
| Regulatory 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.
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
00000 7
1
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
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.
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
000008
2
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
0000 ్లో ప్రారా
3
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
4
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
5
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
:
6
061022 510(k) Number (if known):
Device Name: BIO 1-KIT ® BIOSORB® filled cartridge
Indications for Use:
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.
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