(28 days)
No
The summary describes a bone void filler material and its properties, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an "implant intended to fill bony voids or gaps of the skeletal system" and resorbs and is replaced by bone during the healing process, which directly supports the body's repair processes.
No
The device is an implant intended to fill bony voids or gaps and support bone growth, not to diagnose a medical condition.
No
The device description clearly states it is a "bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler" supplied in a "sterile 7.5ml cartridge" containing "microgranules suspended in an absorbable aqueous gel carrier." This describes a physical implantable material, 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 states that ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details the composition and function of the material as a bone void filler and bone graft substitute. It focuses on its physical and biological properties for promoting bone growth and healing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. ALTAPORE MIS is an implantable medical device used for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
ALTAPORE MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
Altapore MIS System is a is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of Altapore is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. Altapore is composed solely of elements that exist naturally in normal bone (Ca. P. O, H. Si).
Altapore MIS System is supplied in a sterile 7.5ml cartridge and contains Altapore microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. Altapore does not set in-situ following implantation.
Altapore MIS System (hereafter referred to as "Altapore MIS) is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.
Altapore MIS is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.
Altapore MIS is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic. histolopathological, histomorphometric, and mechanical analyses. Altapore MIS undergoes cell-mediated remodeling and is replaced by natural bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities, posterolateral spine and pelvis)
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 data and performance testing were conducted.
The performance of the Altapore MIS System device configurations was assessed by analyzing the Altapore MIS System final product for chemical changes relative to the Altapore predicate product's specification. All testing confirmed that the new configurations had no impact to the chemistry or structure of the Altapore MIS System product.
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for permanent duration, implant device, tissue/bone contact, and FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". ALTAPORE is non-pyrogenic based on material-mediated pyrogenicity testing conducted per ISO 10993-11 and bacterial endotoxin testing performed per USP.
Sterility validation was performed per ANSI/AAMI/ISO 11137-2, "Sterilization of health care products - Radiation - Part 2: Establishing the Sterilization Dose." Package Verification testing is based on Visual Inspection, Seal Strength, and Bubble Leak testing.
Shelf life testing on representative samples supports a shelf-life claim of two (2) years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is placed inside a blue square. The text is stacked in three lines, with "ADMINISTRATION" on the bottom line.
June 30, 2020
Baxter Healthcare Corporation Phillip Romei Specialist, Global Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073
Re: K201464
Trade/Device Name: Altapore MIS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: May 19, 2020 Received: June 4, 2020
Dear Mr. Romei:
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.
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
1
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 (OS) 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 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/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,
Laura Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) TBD
Device Name Altapore MIS
Indications for Use (Describe)
ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
ALTAPORE MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D)Over-The-Counter Use (21 CFR 201 Subpart C) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
| Prescription Use (Part 21 CFR 201 Subpart D) | ||
| Over-The-Counter Use (21 CFR 201 Subpart C) |
|XJ Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Section 5. 510(k) Summary
June 30, 2020
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Phillip Romei Specialist, Global Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: (224) 948-2652 Fax: (224) 270-4119
IDENTIFICATION OF THE DEVICE:
Common Name: Filler, bone void, calcium compound Trade Name: ALTAPORE MIS Classification Panel: 87 Orthopedic Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV
| Model Number | Name |
|---|---|
| 1508032 | Altapore MIS System Applicator + Cartridge, 7.5ml |
| 1508047 | Altapore MIS System Cartridge, 7.5ml |
Table 1. Model Numbers for Altapore MIS
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PREDICATE DEVICE:
| Device | Company | Predicate 510(k) | Clearance Date |
|---|---|---|---|
| Altapore Bone Graft | |||
| Substitute | |||
| (Predicate Device) | Baxter Healthcare | ||
| Corporation | K192363 | January 9, 2020 | |
| Actifuse™ MIS | |||
| System Bone Graft | |||
| Substitute, | |||
| (Predicate Device) | ApaTech Limited1 | K082575 | November 25, 2008 |
Table 2. Predicate Device
1 ApaTech Limited was acquired by Baxter Healthcare Corporation in 2010
The proposed device is substantially equivalent to the predicate devices, Altapore and Actifuse MIS System. Actifuse MIS System is owned and manufactured by Baxter, and has identical packaging, chemical composition, and sterilization as the proposed device. The proposed and predicate Altapore devices have identical chemical composition, physical structure, sterilization, and manufacturing process.
DESCRIPTION OF THE DEVICE:
Altapore MIS System is a is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicatesubstituted calcium phosphate phase of Altapore is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. Altapore is composed solely of elements that exist naturally in normal bone (Ca. P. O, H. Si).
Altapore MIS System is supplied in a sterile 7.5ml cartridge and contains Altapore microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. Altapore does not set in-situ following implantation.
Altapore MIS System (hereafter referred to as "Altapore MIS) is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.
Altapore MIS is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.
5
Altapore MIS is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic. histolopathological, histomorphometric, and mechanical analyses. Altapore MIS undergoes cell-mediated remodeling and is replaced by natural bone.
INDICATIONS FOR USE:
Altapore MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
Altapore MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Altapore MIS resorbs and is replaced with bone during the healing process.
PURPOSE OF SUBMISSION:
The basis for this premarket notification is the addition of the Altapore MIS System configurations to the Altapore product line. The additional configurations consist of a 7.5ml cartridge and delivery applicator and a separate 7.5ml refill cartridge. The proposed new cartridge and applicator materials are currently used in Baxter's Altapore and Actifuse™ MIS System product lines and have been previously cleared under 510(k) premarket notifications K192363 (cleared date 9th Jan, 2020) and K082575 (cleared date 25th Nov, 2008) respectively. The hydroxyapatite granules used in the proposed Altapore MIS System configurations and the predicate devices Actifuse MIS and Altapore are chemically identical. These modifications do not impact the intended use or the fundamental technology of the devices.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed Altapore MIS device has equivalent technological characteristics relative to Baxter's currently cleared Altapore product line, cleared under 510(k) premarket notification K192363 (cleared January 9th, 2020).
DISCUSSION OF NON-CLINICAL DATA:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the proposed devices are appropriately designed for their intended use. All testing was performed on the configuration of the devices presented in this premarket notification.
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Performance Data
The performance of the Altapore MIS System device configurations was assessed by analyzing the Altapore MIS System final product for chemical changes relative to the Altapore predicate product's specification. All testing confirmed that the new configurations had no impact to the chemistry or structure of the Altapore MIS System product.
Biocompatibility
All materials found in these devices that are the subject of this submission have been previously cleared under Baxter's 510(k) premarket notifications K192363 (clearance date January 9th, 2020), and K082575 (clearance date November 25th, 2008).
Biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for permanent duration, implant device, tissue/bone contact, and FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", as recommended in the "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA".
ALTAPORE is non-pyrogenic based on material-mediated pyrogenicity testing conducted per ISO 10993-11 and bacterial endotoxin testing performed per USP.
Sterility
The Altapore MIS System product line is sterilized with radiation. The minimum sterilizing dose (MSD) required to provide a 106 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2, "Sterilization of health care products- Radiation-Part 2: Establishing the Sterilization Dose."
These products are labeled "Sterile". Package Verification testing is based on Visual Inspection, Seal Strength, and Bubble Leak testing.
Shelf Life
Testing performed on representative samples supports a shelf-life claim of two (2) years for Altapore MIS.
CONCLUSION:
Altapore MIS System is as safe and effective as the predicate Altapore Bone Graft Substitute. Both devices share indications for use, technological characteristics, and
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principles of operation. The only differences between the two devices are the changes to the dimensions and materials of the containers housing the devices. The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device.