(269 days)
OCS-B Collagen® (K142040)
No
The device description and performance studies focus on the material properties and biological interactions of a bone substitute and collagen composite, with no mention of AI or ML.
Yes
The device is described as a 'bone substitute' that acts as an 'osteoconductive scaffold for the ingrowth of adjacent viable bone' to replace lost or damaged bone tissue in periodontal, oral, and maxillofacial surgery. This directly addresses medical conditions and aims to restore normal physiological function, which is the definition of a therapeutic device.
No
Explanation: The device is indicated for filling extraction sockets and periodontal defects, and acts as an osteoconductive scaffold for bone ingrowth. It is a regenerative product, not a diagnostic one.
No
The device description clearly states it is a combination of a bone substitute material (hydroxyapatite) and collagen fibers, available in physical forms like blocks and plugs. This indicates it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a material for filling extraction sockets and periodontal defects to enhance preservation of the alveolar ridge and for use in GTR/GBR procedures. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is a combination of a bone substitute and collagen fibers, designed to be implanted into the body.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as an implantable material.
N/A
Intended Use / Indications for Use
InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for:
Filling of extraction sockets to enhance preservation of the alveolar ridge
Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps InterOss® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation.
The product is available in the following shapes and sizes:
Block | 50 | 6 x 6 x 3 | IOC-50
Block | 100 | 6 x 6 x 6 | IOC-100
Block | 250 | 7 x 9 x 8 | IOC-250
Block | 350 | 8 x 10 x 9 | IOC-350
Block | 500 | 10 x 12 x 10 | IOC-500
Plug | 150 | 6 x 10 | IOC-P150
Plug | 250 | 8 x 10 | IOC-P250
Plug | 400 | 11 x 9 | IOC-P400
Plug | 450 | 10 x 12 | IOC-P450
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, periodontal defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical Testing
A series of in vivo and in vitro testing of the subject device was conducted to demonstrate chemical and physical properties, biocompatibility, and substantial equivalence of the subject device to its predicate device.
Physical/Chemical Properties
Collagen component was assessed for collagen stability, purity, resistance to trypsin, amino acid analysis, and ELISA assays. Amino acid analysis showed that the collagen contains 80-87% protein (w/w) and the hydroxyproline content within range from 9.4-10.04% (w/w), and ELISA confirmed the presence of predominantly Type I collagen. SDS PAGE on porcine collagen showed signature alpha bands while exposure to collagenase showed no bands confirming collagen purity. Resistance to trypsin was confirmed by a temporal trypsin resistance test.
InterOss Collagen was evaluated for the porous structure/interconnected pores via scanning electron microscopy. Porosity measurement was performed using mercury porosimetry and confirmed porosity greater than 75% while the average pore diameter ranged from 0.12-0.15 um. Surface area was measured using Brunauer-Emmett-Teller method that confirmed that the article measures than 75 m²/g. Compressive and elastic modulus testing showed the values of >1 MPa and >3 MPa respectively at 50% compressive strain. Total residual crude fat analysis using chemical ether extraction showed fat content to be less than 3% (w/w). The moisture content in InterOss Collagen measured using thermogravimetric analyzer showed values of approximately 3.1% (w/w). Peak denaturation temperature was measured to be between 210-230°C using Differential Scanning Calorimetry. No heavy metals within the detection limit (1 ppm) were found in InterOss Collagen when measured using ICP-MS. Water absorption testing showed InterOss Collagen absorbs more than 100% of its weight when immersed in deionized water at room temperature. Water solubility test found InterOss Collagen to be not soluble.
Biocompatibility Testing
A series of in vitro and in vivo biocompatibility testing was performed to assess the safety of the subject device in accordance with ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1.
Results: Non-mutagenic, Non-sensitizer, Non-irritant, Non-toxic, Non-cytotoxic. Minimum tissue reaction at 4, 8, and 13 weeks of implantation with no adverse tissue reaction to the host.
Animal Testing
Study type: Canine two-wall intrabony defect model.
The performance of the device was compared to the predicate device, OCS-B Collagen (K142040), and an empty control in beagle dogs with mandibular defects.
Key results: By all the parameters evaluated in the study, biocompatibility, performance, and healing of InterOss Collagen treated defects were indistinguishable from those treated with the predicate. The results demonstrate performance substantially equivalent to the predicate device OCS-B Collagen when used as intended.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
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.
OCS-B Collagen® (K142040)
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.
InterOss® (K151209)
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
SigmaGraft Inc. % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Ste 610 Houston, Texas 77054
Re: K221808
Trade/Device Name: InterOss® Collagen Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: March 8, 2023 Received: March 8, 2023
Dear Dave Kim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221808
Device Name InterOss® Collagen
Indications for Use (Describe)
InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for:
Filling of extraction sockets to enhance preservation of the alveolar ridge
Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Rx + 21 CFR 801 Subpart D)□ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Rx + 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ☑ Prescription Use (Rx + 21 CFR 801 Subpart D) | |||
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for SigmaGraft. The logo consists of two parts: a stylized letter "Z" with the word "GRAFT" above and "Biomaterials" below, and the word "SigmaGraft" in a larger, bolder font. The logo is in a dark blue color.
FDA Traditional 510(k) Summary K221808
1. Submitter's Information
| Submitter: | SigmaGraft, Inc.
575 Sally Place
Fullerton, CA 92831, USA |
|-----------------|-----------------------------------------------------------------|
| Contact Person: | Elcin Chang |
| Phone Number: | +1-714-525-0112 |
| Fax Number: | +1-714-525-0116 |
| Prepared by: | Elcin Chang, General Manager |
| Email: | e.chang@sigmagraft.com |
| Date Prepared: | March 17, 2023 |
2. Name of the Device
| Trade Names: | InterOss Collagen |
|---|---|
| Common Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material, Collagen |
| Regulation Number: | §872.3930 |
| Device Classification: | II |
| Product Code(s): | NPM |
| Classification Panel: | Dental |
3. Predicate Device
| Primary Predicate: | OCS-B Collagen® (K142040) |
|---|---|
| Common Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material, Collagen |
| Regulation Number: | §872.3930 |
| Device Classification: | II |
| Product Code(s): | NPM |
| Classification Panel: | Dental |
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Image /page/4/Picture/0 description: The image contains the logo for Sigma Graft Biomaterials. The logo is split into two parts. On the left is the word "GRAFT" stacked vertically with a stylized "Z" shape next to it, and the word "Biomaterials" underneath. To the right of that is the word "SigmaGraft" in a larger, bold font.
4. Reference Device
| Primary Predicate: | InterOss® (K151209) |
|---|---|
| Classification Name: | Bone Grafting Material |
| Regulation Number: | §872.3930 |
| Device Classification: | II |
| Product Code(s): | NPM |
| Classification Panel: | Dental |
5. Device Description
InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps InterOss® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation.
| Type | Weight
(mg) | Dimension
(mm) | Ref# |
|-------|----------------|-------------------|----------|
| Block | 50 | 6 x 6 x 3 | IOC-50 |
| Block | 100 | 6 x 6 x 6 | IOC-100 |
| Block | 250 | 7 x 9 x 8 | IOC-250 |
| Block | 350 | 8 x 10 x 9 | IOC-350 |
| Block | 500 | 10 x 12 x 10 | IOC-500 |
| Plug | 150 | 6 x 10 | IOC-P150 |
| Plug | 250 | 8 x 10 | IOC-P250 |
| Plug | 400 | 11 x 9 | IOC-P400 |
| Plug | 450 | 10 x 12 | IOC-P450 |
The product is available in the following shapes and sizes:
6. Intended Use
InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss® Collagen is recommended for:
- Filling of extraction sockets to enhance preservation of the alveolar ridge ●
- Filling of periodontal defects in extraction sockets in conjunction with products intended for Guided ● Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
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Image /page/5/Picture/0 description: The image features the logo for SigmaGraft Biomaterials. On the left is a stylized blue letter 'Z' with the word 'GRAFT' above and 'Biomaterials' below. To the right is the word 'SigmaGraft' in a bold, dark blue font. The logo is set against a dark blue background.
7. Summary/Comparison of Technical Characteristics
The subject device and the predicate device have the same indications for use. The subject device has substantially equivalent technological characteristics to the marketed predicate device.
| Feature | InterOss Collagen | OCS-B Collagen (K142040) | InterOss ® (K151209) |
|---|---|---|---|
| Indications for | |||
| Use | • Filling of extraction | ||
| sockets to enhance | |||
| preservation of the alveolar | |||
| ridge | |||
| • Filling of periodontal | |||
| defects in extraction | |||
| sockets in conjunction | |||
| with products intended for | |||
| Guided Tissue | |||
| Regeneration (GTR) and | |||
| Guided Bone | |||
| Regeneration (GBR) | • Augmentation for | ||
| reconstructive treatment of | |||
| alveolar ridge | |||
| • Filling of infrabony | |||
| periodontal defects | |||
| • Filling of defects after root | |||
| resection, apicoectomy, | |||
| and cystectomy | |||
| • Filling of extraction | |||
| sockets to enhance | |||
| preservation of the alveolar | |||
| ridge | |||
| • Elevation of maxillary | |||
| sinus floor | |||
| • Filling of periodontal | |||
| defects in conjunction with | |||
| products intended for | |||
| Guided Tissue Generation | |||
| (GTR) and Guided Bone | |||
| Regeneration (GBR) | |||
| • Filling of peri-implant | • Augmentation or | ||
| reconstructive treatment | |||
| of the alveolar ridge | |||
| • Filling of infrabony | |||
| periodontal defects | |||
| • Filling of defects after | |||
| root resection, | |||
| apicoectomy, and | |||
| cystectomy | |||
| • Filling of extraction | |||
| sockets to enhance | |||
| preservation of the | |||
| alveolar ridge | |||
| • Elevation of the | |||
| maxillary sinus floor | |||
| • Filling of periodontal | |||
| defects in conjunction | |||
| with products intended | |||
| for Guided Tissue | |||
| Regeneration (GTR) and | |||
| Guided Bone | |||
| defects in conjunction with | |||
| products intended for | |||
| Guided Bone Regeneration | Regeneration (GBR) | ||
| • Filling of peri-implant | |||
| defects in conjunction | |||
| with products intended | |||
| for Guided Bone | |||
| Regeneration (GBR) | |||
| Physical Form | Block and plug shaped | Block and plug shaped | White granules in vial and |
| syringe | |||
| Color | White to off-white | White to off-white | White to off-white |
| Material | |||
| Composition | • Anorganic bone mineral | ||
| (calcium phosphate) | |||
| • Type I Collagen | • Anorganic bone mineral | ||
| (calcium phosphate) | |||
| • Type I Collagen | • Anorganic bone mineral | ||
| (calcium phosphate) | |||
| Size (Dimension | |||
| and weight) | Block (6x6x3mm, 50 mg) | ||
| Block (6x6x6mm, 100 mg) | |||
| Block (7x8x9mm, 250 mg) | |||
| Block (8x9x10mm, 350 mg) | |||
| Block (10x10x12mm, 500 | |||
| mg) | |||
| Plug (6x10mm, 150mg) | |||
| Plug (8x10mm, 250mg) | |||
| Plug (11x9mm, 400mg) | |||
| Plug (10x12mm, 450mg) | Block (6x6x3mm, 50 mg) | ||
| Block (6x6x6mm, 100 mg) | |||
| Block (7x8x9mm, 250 mg) | |||
| Block (9x10x11mm, 500 | |||
| mg) | |||
| Cylinderic (4.6x40mm, | |||
| 250mg) | |||
| Cylinderic (5.6x45mm, 500 | |||
| mg) | Via Small granules (0.25- | ||
| 1.00mm): 0.25g, 0.5g, 1.0g, | |||
| 2.0g or 5.0g | |||
| Large granules (1.00- | |||
| 2.00mm): 0.5g, 1.0g, or | |||
| 2.0g | |||
| Syringe | |||
| Small granules (0.25- | |||
| 1.00mm): 0.25cc, 0.5cc, or | |||
| 1.0cc | |||
| Large granules (1.00- | |||
| 2.00mm): 0.5cc, 1.0cc, or | |||
| 1.5cc | |||
| Source of bone | Bovine | Bovine | Bovine |
| Source of | |||
| collagen | Porcine | Porcine | Not applicable |
| Physical | |||
| morphology | Trabecular, interconnecting | ||
| macro and micro pores | Trabecular, interconnecting | ||
| macro and micro pores | Trabecular, interconnecting | ||
| macro and micro pores | |||
| pH | 7.18 | 6.96 | 7.86 |
| Swell ratio % | |||
| (w/w) | 179.8 | 116.8 | Not applicable |
| Surface area | 77.41 m²/g | 52.10 m²/g | 114.45 m²/g |
| Moisture content | 3.1% | 3.12% | 2.04% |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Performance | Bone formation | Bone formation | Bone formation |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Sterility | Sterile, Sal 10-6 Gamma | ||
| irradiation | Sterile, Sal 10-6 Gamma | ||
| irradiation | Sterile, Sal 10-6 Gamma | ||
| irradiation |
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Image /page/6/Picture/0 description: The image contains the logo for SigmaGraft Biomaterials. The logo consists of a stylized letter "S" on the left, with the word "GRAFT" stacked vertically above the word "Biomaterials". To the right of the logo is the word "SigmaGraft" in a larger, bold font. The text and logo are in a dark blue color.
8. Non-clinical Testing
A series of in vivo and in vitro testing of the subject device was conducted to demonstrate chemical and physical properties, biocompatibility, and substantial equivalence of the subject device to its predicate device. The following
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performance data are provided in support of the substantial equivalence determination.
Physical/Chemical Properties
Collagen component was assessed for collagen stability, purity, resistance to trypsin, amino acid analysis, and ELISA assays were performed on collagen samples. Amino acid analysis showed that the collagen contains 80-87% protein (w/w) and the hydroxyproline content within range from 9.4-10.04% (w/w), and ELISA confirmed the presence of predominantly Type I collagen. SDS PAGE on porcine collagen showed signature alpha bands while exposure to collagenase showed no bands confirming collagen purity. Resistance to trypsin was confirmed by a temporal trypsin resistance test.
InterOss Collagen was evaluated for the porous structure/interconnected pores via scanning electron microscopy. Porosity measurement was performed using mercury porosimetry and confirmed porosity greater than 75% while the average pore diameter ranged from 0.12-0.15 um. Surface area was measured using Brunauer-Emmett-Teller method that confirmed that the article measures than 75 m²/g. Compressive and elastic modulus testing showed the values of >1 MPa and >3 MPa respectively at 50% compressive strain. Total residual crude fat analysis using chemical ether extraction showed fat content to be less than 3% (w/w). The moisture content in InterOss Collagen measured using thermogravimetric analyzer showed values of approximately 3.1% (w/w). Peak denaturation temperature was measured to be between 210-230°C using Differential Scanning Calorimetry. No heavy metals within the detection limit (1 ppm) were found in InterOss Collagen when measured using ICP-MS. Water absorption testing showed InterOss Collagen absorbs more than 100% of its weight when immersed in deionized water at room temperature. Water solubility test found InterOss Collagen to be not soluble.
Biocompatibility Testing
A series of in vitro and in vivo biocompatibility testing was performed to assess the safety of the subject device. Testing was determined in accordance with ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1 for the biological evaluation of medical devices within a risk management process.
8
| Test | Standards | Results |
|---|---|---|
| Mouse Lymphoma forward mutation | ||
| assay | ISO 10993-3, OECD | |
| 476, OECD 490 | Non-mutagenic | |
| Kligman Maximization Sensitization Test | ISO 10993-10 | Non-sensitizer |
| Genotoxicity (Mammalian Erythrocyte | ||
| Micronucleus) Test | ISO 10993-3, | |
| OECD Test No. 474. | Non-mutagenic | |
| Primary buccal irritation Test | ISO 10993-10 | Non-irritant |
| Acute Systemic Toxicity Test | ISO 10993-11 | Non-toxic |
| Cytotoxicity L929 Neutral Red uptake test | ISO 10993-5 | Non-cytotoxic |
| Genotoxicity (Ames: Bacterial Reverse | ||
| Mutation) Test | ISO 10993-3 | Non-mutagenic |
| 90 day Subchronic Toxicity Test | ISO 10993-11 | Non-toxic |
| Local effects after Implantation Test | ISO 10993-6 | Minimum tissue reaction at 4, 8, and |
| 13 weeks of implantation and no | ||
| adverse tissue reaction to the host |
The biocompatibility testing performed is summarized in the table below.
Animal Testing
The performance of the device in a canine two-wall intrabony defect model was compared to the performance of the predicate device, OCS-B Collagen. The objective of this study was to evaluate the in vivo performance, local effects following implantation, and systemic toxicity of the test article, Inter Oss Collagen, in comparison to a predicate and empty control in beagle dogs with mandibular defects as a dental application.
By all the parameters evaluated in the study, biocompatibility, performance, and healing of InterOss Collagen treated defects were indistinguishable from those treated with the predicate. The results demonstrate performance substantially equivalent to the predicate device OCS-B Collagen when used as intended.
9. Animal Tissue Management
Animal tissues are managed in accordance with the following standards and guidance documents:
- ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices Part . 1: Analysis and Risk Management
- ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices Part ● 2: Controls on Sourcing, Collection, and Handling
- ISO 22442-3 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices Part . 3: Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents
- . Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Guidance for Industry and Food and Drug Administration Staff, CDRH, FDA, March 15, 2019
- . FDA Guidance for Industry - Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell
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Image /page/9/Picture/0 description: The image contains the logo for SigmaGraft Biomaterials. The logo features the word "GRAFT" stacked vertically with a stylized "S" to the left of it. Below the word "GRAFT" is the word "Biomaterials". To the right of the logo is the word "SigmaGraft" in a larger font. The logo is in blue and white.
Lines of Human or Animal Origin, CDER, CBER, September 1998
10. Sterilization
Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of health care products -Radiation Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices, ISO 11137-2 Sterilization of health care products - Radiation Part 2 Establishing the sterilization dose, and ISO 11737 Sterilization of Medical Devices - Microbiological Method - Determination of the Population of Microorganisms on Products.
11. Pyrogenicity
This device is non-pyrogenic. Each batch of product manufactured is tested for endotoxin per the Limulus Amebocyte Lysate (LAL) endotoxin test, USP . Material mediated pyrogenicity was evaluated by USP testing, as finished product release test.
12. Shelf Life and Stability
Product and packaging stability was determined using real-time aging data. Performance testing of packaging system was tested in accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. Selection, qualification, and validation of packaging were conducted in accordance with ISO 11607 Packaging for Terminally Sterilized Medical Devices - Requirements for Materials, Sterile Barrier Systems, and Packaging Systems.
13. Viral Inactivation
Viral inactivation studies were performed in accordance with ISO 22442-3 to ensure the viral safety of the product.
14. Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
15. Conclusion
Chemical, physical, and biocompatibility tests as well as pre-clinical data show that the subject device is substantially equivalent to the predicate device. Comparison with the predicate device shows that the device has similar specifications and performance. Therefore, the conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate device.