(241 days)
No
The summary describes a physical bone grafting material and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a medical product intended to treat various bone defects and aid in regeneration, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a bone grafting material intended for reconstructive treatment and filling defects, not for diagnosing conditions.
No
The device is a physical bone grafting material composed of porcine bone mineral and collagen, supplied as sterile sponges. It is not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "bone grafting in periodontal, oral and maxillofacial surgeries." This involves direct application to the patient's body to promote bone regeneration.
- Device Description: The description details a "bone mineral with collagen composite" designed to be implanted into surgical defects.
- 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.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for therapeutic purposes (bone grafting).
N/A
Intended Use / Indications for Use
Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.
Porcine Mineral Collagen Composite is indicated for:
- · Augmentation or 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 Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR),
Product codes
NPM
Device Description
Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.
The product is available in the following shape and sizes:
Product Shape: Plug, Dimensions: 10mm (5mm dry) x 17mm (diameter x length)
Product Shape: Umbrella, Dimensions: 17mm (13mm dry) x 10mm (diameter x height)
Product Shape: Umbrella, Dimensions: 22mm (17mm dry) x 12mm (diameter x height)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, infrabony periodontal defects, defects after root resection, apicoectomy, and cystectomy, extraction sockets, maxillary sinus floor, periodontal defects, peri-implant 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
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices.
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.
- Cytotoxicity (L929 MEM Elution Test, ISO 10993-5): Non-cytotoxic
- Sensitization (Guinea Pig Maximization, ISO 10993-10): No evidence of causing delayed dermal contact sensitization in the guinea pig
- Irritation Intracutaneous Reactivity (ISO Intracutaneous Reactivity in Rabbits, ISO 10993-10): No evidence of irritation or toxicity
- Acute Systemic Toxicity (Acute Systemic Toxicity in Mice, ISO 10993-3): No mortality or evidence of systemic toxicity
- Pyrogenicity (USP (151) Rabbit Pyrogen Study, USP Bacterial Endotoxin Test): Non-pyrogenic
- Genotoxicity (Mouse Lymphoma Assay, ISO 10993-3): No evidence of causing increase in the mean mutant frequency of the L5178Y/TK+/- cell line either in the presence or absence of metabolic inactivation. The test article was not mutagenic.
- Genotoxicity (Ames Assay): Non-mutagenic to Salmonella typhimurium and to Escherichia coli strain WP2uvra
- Implantation (Implantation in Canine Intrabony Defect Model, ISO 10993-6): Minimum tissue reaction at 4, 8 and 13 weeks of implantation and no adverse tissue reaction to the host
- Subacute / Subchronic / Chronic Toxicity (Implantation in Canine Intrabony Defect Model, ISO 10993-11): Minimum tissue reaction at 4, 8, and 13 weeks of implantation and no adverse tissue reaction to the host
A Toxicology Risk Assessment was performed to evaluate formaldehyde residuals. The assessment concluded that the amount of formaldehyde residual for single product use has been addressed and no long-term toxicological effects are anticipated.
Bench Testing:
In vitro product characterization testing was performed to evaluate material properties, biological properties, chemical and physical properties. Testing of the anorganic bone mineral component was conducted in accordance with ASTM F1581.
- Mineral Content: Mineral content similar to predicate devices
- Size: Sizes similar to predicate devices
- Calcium to Phosphate Ratio (mineral only): Ratio similar to predicate device
- Scanning Electron Micrograph (SEM): Morphologies similar to reference device
- X-Ray Diffraction: Similar diffraction patterns to reference device
- IR Spectroscopy: Similar functional groups to reference device
- Porosity: Porosity similar to predicate
- pH: pH similar to predicate device
- Absorbency: ≥ 5ml/g
- Pyrogenicity: Non-pyrogenic
Animal Testing:
The performance of the device in a canine one-wall intrabony defect model was compared to the performance of the predicate device, Bio-Oss Collagen. Radiographic, Micro CT, Histology, and Histomorphometry analyses were conducted following implantation at 4, 8, and 13 weeks for the subject device, reference device, and sham negative control. The results demonstrate performance substantially equivalent to the predicate device Bio-Oss Collagen when used as intended.
Sterilization: Validation performed in accordance with ISO 11137-1, ISO 11137-2, and ISO 11737.
Pyrogenicity: Products are non-pyrogenic. Each batch is tested for endotoxin per USP .
Shelf Life and Stability: Product and packaging stability determined using data and performance testing of packaging system in accordance with ASTM D4169 and ISO 11607.
Viral Inactivation: Viral inactivation studies performed in accordance with ISO 22442-3.
Clinical Studies: Clinical performance data was not required to determine substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Below the FDA logo is the word ADMINISTRATION.
4/2/2021
Collagen Matrix, Inc. Gloria Zuclich Director, Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436
Re: K202183
Trade/Device Name: Porcine Mineral Collagen Composite Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: February 28, 2021 Received: March 2, 2021
Dear Gloria Zuclich:
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.
1
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 53 1 -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 mediation-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/cdrl-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-ind-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,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Porcine Mineral Collagen Composite
Indications for Use (Describe)
Porcine Mineral Collagen Composite is indicated for:
- · Augmentation or 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 Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR),
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Production, Post-ATF MRA Import/Export | ☐ Own-Use, Post-ATF MRA Import/Export |
|---|---|
| ------------------------------------------------------------------------------ | --------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Collagen Matrix, Inc.
510(k) Summary 510(k) Submission No.: K202183 Porcine Mineral Collagen Composite
Page 1 of 6
510(k) SUMMARY
| 1. Applicant Information |
|---|
| Applicant Name: Collagen Matrix, Inc. |
| Address: 15 Thornton Road |
| Oakland, New Jersey 07436 |
| Telephone: (201) 405-1477 |
| Fax: (201) 405-1355 |
| Contact Person: Gloria Zuclich |
| Director of Regulatory Affairs |
| gzuclich@collagenmatrix.com |
| Date Prepared: April 2, 2021 |
| 2. Name of the Device |
| Device Trade Name: Porcine Mineral Collagen Composite |
| Device Common Name(s): Bone Grafting Material |
| Device Classification Name: Bone Grafting Material, Animal Source |
| 872.3930 |
| NPM |
| Class II |
| 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed |
| Primary Predicate Device: Bio-Oss® Collagen |
| Geistlich-Pharma AG |
| K033815 |
| Reference Device(s): Anorganic Bone Mineral with Collagen in Delivery |
| Applicator |
| Collagen Matrix, Inc. |
| K171008 |
| Collagen Dental Membrane – Porcine Type I |
| Collagen |
| Collagen Matrix, Inc. |
| K110600 |
| Collagen Dental Wound Dressings |
| Collagen Matrix, Inc. |
| K122115 |
4
4. Description of the Device
Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.
The product is available in the following shape and sizes:
| Product Shape | Dimensions |
|---|---|
| Plug | 10mm (5mm dry) x 17mm (diameter x length) |
| Umbrella | 17mm (13mm dry) x 10mm (diameter x height) |
| Umbrella | 22mm (17mm dry) x 12mm (diameter x height) |
5. Intended Use
Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.
Porcine Mineral Collagen Composite is indicated for:
- Augmentation or 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 . Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone . Regeneration (GBR).
6. 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 as the cited legally marketed predicate device. Differences include the physical form, product size range and/or product weight range. Differences in the physical form and product size range have been determined to be minor and are substantiated when compared to that of the cited reference device. The difference in product weight range offered for the subject device falls within the range supplied for the primary predicate device.
5
| Feature | Porcine Mineral Collagen
Composite
(This Submission) | Bio-Oss® Collagen
(K033815) | Anorganic Bone Mineral
with Collagen in Delivery
Applicator (K171008) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Augmentation or
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• Elevation of maxillary
sinus floor
• Filling of periodontal
defects in conjunction
with products intended
for Guided Tissue
Regeneration (GTR) and
Guided Bone
Regeneration (GBR)
• Filling of peri-implant
defects in conjunction
with products intended
for Guided Bone
Regeneration (GBR) | Augmentation or
reconstructive treatment
of alveolar ridge
• Filling of 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
Regeneration (GTR) and
Guided Bone
Regeneration (GBR)
• Filling of peri-implant
defects in conjunction
with products intended
for Guided Bone
Regeneration (GBR) | Augmentation or
reconstructive treatment
of alveolar ridge
• Filling of infrabony
periodontal defects
• Filing of defects after
root resection,
apicoectomy, and
cystectomy
• Filing 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
Regeneration (GTR) and
Guided Bone
Regeneration (GBR)
• Filing of peri-implant
defects in conjunction
with products intended
for Guided Bone
Regeneration (GBR) |
| Physical Form | Preformed sponge matrix | Block Shaped | Preformed sponge matrix |
| 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)
• Type I collagen |
| Size (Dimension) | 10mm x 17mm
17mm x 10mm
22mm x 12mm | N/A | 4.8mm x 12.5mm
4.8mm x 25.0mm
4.8mm x 37.5mm |
| Weight | 80mg
175mg
350mg | 50mg
100mg
250mg
500mg | N/A |
| Cross-linking | Crosslinked with
formaldehyde | Unknown | Crosslinked with
formaldehyde |
| Biocompatibility | Biocompatible
ISO 10993 | Biocompatible
ISO 10993 | Biocompatible
ISO 10993 |
| Sterility | Sterile, SAL 10-6
Gamma irradiation
ISO 11137 | Sterile, SAL 10-6
Gamma irradiation | Sterile, SAL 10-6
Gamma irradiation
ISO 11137 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Single Use/
Reuse | Single use only | Single use only | Single use only |
6
7. Performance Data
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices. The following performance data are provided in support of the substantial equivalence determination.
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. The biocompatibility testing performed is summarized in the table below.
| Test | Test Method | Results |
|---|---|---|
| Cytotoxicity | L929 MEM Elution Test, ISO | |
| 10993-5 | Non-cytotoxic | |
| Sensitization | Guinea Pig Maximization, | |
| ISO 10993-10 | No evidence of causing delayed | |
| dermal contact sensitization in | ||
| the guinea pig | ||
| Irritation Intracutaneous | ||
| Reactivity | ISO Intracutaneous Reactivity in | |
| Rabbits, ISO 10993-10 | No evidence of irritation or | |
| toxicity | ||
| Acute Systemic | ||
| Toxicity | Acute Systemic Toxicity in Mice, | |
| ISO 10993-3 | No mortality or evidence of | |
| systemic toxicity | ||
| Pyrogenicity | USP (151) Rabbit Pyrogen | |
| Study | ||
| USP Bacterial Endotoxin | ||
| Test | Non-pyrogenic | |
| Genotoxicity | Mouse Lymphoma Assay, ISO | |
| 10993-3 | No evidence of causing increase | |
| in the mean mutant frequency of | ||
| the L5178Y/TK+/- cell line either | ||
| in the presence or absence of | ||
| metabolic inactivation. The test | ||
| article was not mutagenic | ||
| Genotoxicity | Ames Assay | Non-mutagenic to Salmonella |
| typhimurium and to Escherichia | ||
| coli strain WP2uvra | ||
| Implantation | Implantation in Canine Intrabony | |
| Defect Model, ISO 10993-6 | Minimum tissue reaction at 4, 8 | |
| and 13 weeks of implantation | ||
| and no adverse tissue reaction | ||
| to the host |
7
| Test | Test Method | Results |
|---|---|---|
| Subacute / Subchronic / | ||
| Chronic Toxicity | Implantation in Canine Intrabony | |
| Defect Model, ISO 10993-11 | Minimum tissue reaction at 4, 8, | |
| and 13 weeks of implantation | ||
| and no adverse tissue reaction | ||
| to the host |
A Toxicology Risk Assessment was performed to evaluate formaldehyde residuals. The assessment included an evaluation of information presented in scientific literature and biocompatibility testing conduct on the subject device as well as similar devices. The results of the assessment concluded that the amount of formaldehyde residual for single product use has been addressed. No long-term toxicological effects are anticipated. Risk of exposure to formaldehyde has not been addressed when multiple products are used in a single patient procedure.
Bench Testing
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate devices. A series of bench tests were conducted to evaluate material properties, biological properties, chemical and physical properties as indicated. Testing of the anorganic bon mineral component was conducted in accordance with ASTM F1581 Standard Specifications for Composition of Anorganic Bone for Surgical Implants.
| Test | Results |
|---|---|
| Mineral Content | Mineral content similar to predicate devices |
| Size | Sizes similar to predicate devices |
| Calcium to Phosphate | |
| Ratio (mineral only) | Ratio similar to predicate device |
| Scanning Electron | |
| Micrograph (SEM) | Morphologies similar to reference device |
| X-Ray Diffraction | Similar diffraction patterns to reference device |
| IR Spectroscopy | Similar functional groups to reference device |
| Porosity | Porosity similar to predicate |
| pH | pH similar to predicate device |
| Absorbency | ≥ 5ml/g |
| Pyrogenicity | Non-pyrogenic |
Animal Testing
The performance of the device in a canine one-wall intrabony defect model was compared to the performance of the predicate device. Bio-Oss Collagen. Radiographic, Micro CT. Histology and Histomorphometry analyses were conducted following implantation at 4, 8, and 13 weeks for the subject device, reference device and sham negative control. The results demonstrate performance substantially equivalent to the predicate device Bio-Oss Collagen when used as intended.
8
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 Lines of Human or Animal Origin, CDER, September 1998
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.
Pyrogenicity
Porcine Mineral Collagen Composite products are non-pyrogenic. Each batch of product manufactured is tested for endotoxin per the Limulus Amebocyte Lysate (LAL) endotoxin test. USP . as a finished product release test.
Shelf Life and Stability
Product and packaging stability was determined using 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.
Viral Inactivation
Viral inactivation studies were performed in accordance with ISO 22442-3 to ensure the viral safety of the product.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
8. Conclusions Drawn from Non-clinical Studies
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.