(58 days)
Not Found
No
The device description focuses on the material composition and physical properties of a bone void filler, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an implantable bone void filler intended to fill bony voids or gaps and acts as a bone graft extender. It is not designed to provide therapeutic treatment for a disease or condition.
No
The device is a bone void filler intended to fill bony voids or gaps. It is a therapeutic device that aids in the healing process of bone rather than diagnosing a condition.
No
The device is a physical implantable bone void filler, not a software application.
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 SHAPE is an implant intended to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function within the body.
- Device Description: The description details a bone void filler made of calcium phosphate and a carrier, designed to be implanted.
- Lack of Diagnostic Function: There is no mention of this device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples (blood, urine, tissue, etc.).
Therefore, ALTAPORE SHAPE is a medical device, specifically a bone graft substitute, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. 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 SHAPE resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
ALTAPORE SHAPE 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 SHAPE is similar to human cancellous bone and is intended to support bone growth with macro and micro-porosity. The microgranule phase ALTAPORE SHAPE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).
ALTAPORE SHAPE is supplied as a shaped wax-like putty in a sterile pouch containing ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable Alkylene Oxide co-polymer carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.
ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.
ALTAPORE SHAPE 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 SHAPE 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 SHAPE 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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed for the same intended use.
Performance Testing- Bench: The proposed device is identical to the ALTAPORE SHAPE predicate device cleared under K191513. As such, no additional bench testing was conducted. All previous verification and validation testing performed for the ALTAPORE SHAPE predicate device, cleared under K191513, are applicable to the proposed product. The following in vitro studies were conducted as part of the predicate submission to evaluate the performance characteristics of ALTAPORE SHAPE: Bioactive properties.
Performance Testing- Animal: A preclinical animal study was conducted to evaluate the following performance characteristics of ALTAPORE SHAPE for use in posterolateral spine fusion procedures as a bone graft extender. This study is presented again to support the performance of ALTAPORE SHAPE as a stand-alone graft substitute in posterolateral spinal fusion procedures: Effectiveness for use in posterolateral fusion.
Biocompatibility: There are no changes to ALTAPORE SHAPE compared to the predicate device submission K191513. A summary of testing previously cleared under K191513 is included. Biocompatibility assessments were conducted based on ISO-10993-1 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 FDA guidance document, Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device. The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation, System Toxicity, Pyrogen, Genotoxicity, Implantation.
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.
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2020
Baxter Healthcare Corporation Phillip Romei Specialist, Global Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, Illinois 60073
Re: K200640
Trade/Device Name: Altapore Shape Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: March 9, 2020 Received: March 11, 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,
for
Jesse Muir, 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
2
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 Shape
Indications for Use (Describe)
ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. 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 SHAPE resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Over-The-Counter Use (21 CFR 801 Subpart C)
3
Baxter
Section 5. 510(k) Summary
March 03, 2020
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Phillip Romei Specialist, 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: Bone Void Filler Trade/Device Name: ALTAPORE SHAPE Classification Panel: 87 Orthopedic Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV
| Model Number | Name |
|---|---|
| 1508043 | ALTAPORE SHAPE, 1.6 ml small cylinder |
| 1508044 | ALTAPORE SHAPE, 2.6 ml medium cylinder |
| 1508045 | ALTAPORE SHAPE, 8 ml large cylinder |
| 1508046 | ALTAPORE SHAPE, 15.8 ml large strip |
Table 1. Model Numbers for ALTAPORE
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Image /page/4/Picture/1 description: The image shows the word "Baxter" in a bold, sans-serif font. The word is slightly italicized, giving it a dynamic appearance. The color of the text is a dark gray, providing a strong contrast against the white background.
PREDICATE AND REFERENCE DEVICES:
ALTAPORE SHAPE is substantially equivalent to the following predicate and reference devices (Table 2):
| Device | Company | 510(k) | Clearance Date |
|---|---|---|---|
| ALTAPORE | |||
| (Predicate Device) | Baxter Healthcare | ||
| Corporation | K192363 | January 09, 2020 | |
| ALTAPORE SHAPE | |||
| (Predicate Device) | Baxter Healthcare | ||
| Corporation | K191513 | October 19, 2019 | |
| MASTERGRAFT® Putty | |||
| (Predicate Device) | Medtronic Sofamor Danek | ||
| USA, Inc. | K140375 | April 18, 2014 |
Table 2. Predicate Devices
DESCRIPTION OF THE DEVICE:
ALTAPORE SHAPE 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 SHAPE is similar to human cancellous bone and is intended to support bone growth with macro and micro-porosity. The microgranule phase ALTAPORE SHAPE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).
ALTAPORE SHAPE is supplied as a shaped wax-like putty in a sterile pouch containing ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable Alkylene Oxide co-polymer carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.
ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.
ALTAPORE SHAPE 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 SHAPE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic,
5
histolopathological, histomorphometric, and mechanical analyses. ALTAPORE SHAPE undergoes cell-mediated remodeling and is replaced by natural bone.
INDICATIONS FOR USE
ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis).
ALTAPORE SHAPE can be used by itself, or with autograft as a bone graft extender in posterolateral spinal fusion procedures. 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 SHAPE resorbs and is replaced with bone during the healing process.
Indications for Use statement is consistant with the recently cleared posterolateral spinal fusion procedure indication of the ALTAPORE predicate device (K192363), and the previously cleared use of ALTAPORE SHAPE as a bone void filler (K191513). Both ALTAPORE SHAPE and ALTAPORE consist of identical silicate-substituted calcium phosphate granules, and the differences in absorbable carrier phase do not alter the intended therapeutic use of the devices nor do they affect the safety and effectiveness of the device relative to the predicate or reference devices. Both the proposed and predicate devices have the same intended use for the treatment of filling bony voids or gaps of the skeletal system.
PURPOSE OF SUBMISSION
No material changes to ALTAPORE SHAPE have been made since the clearance of K191513.The purpose of this submission is to align the ALTAPORE SHAPE posterolateral spine fusion indications for use with that of the ALTAPORE predicate device previously cleared under K192363. The hydroxyapatite granules used in ALTAPORE SHAPE are identical to those in the predicate device ALTAPORE.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
ALTAPORE SHAPE is substantially equivalent to the predicate devices previously cleared under 510(k) premarket notification, K192363, K191513, and K140375. The function and intended use of the proposed device are equivalent to the predicate devices. Table 3 below provides a comparison of the technological characteristics of the proposed and predicate devices.
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| Features | Predicate Device
(K140375)
MASTERGRAFT®
Putty | Predicate Device-
(K191513):
ALTAPORE
SHAPE | Predicate Device
(K192363):
ALTAPORE | Proposed Device:
ALTAPORE
SHAPE |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Chemical
Composition | Calcium Phosphate
Salt:
Purified collagen of
bovine origin and
biphasic calcium
phosphate ceramic.
Type I bovine
collagen.
15 percent
hydroxyapatite and 85
percent ß-tricalcium
phosphate formulation. | Calcium Phosphate
Salt phase:
Phase-pure silicon-
substituted
hydroxylapatite
$Ca10(PO4)(6-x)(SiO4)(x)(OH)(2-X)$
Silicon is present in
0.8 wt% amounts.
Carrier:
Absorbable Alkylene
Oxide Co-polymer | Calcium Phosphate
Salt phase:
Phase-pure silicon-
substituted
hydroxylapatite
$Ca10(PO4)(6-x)(SiO4)(x)(OH)(2-X)$
Silicon is present in
0.8 wt% amounts.
Carrier:
Absorbable Aqueous
Gel | Calcium Phosphate
Salt phase:
Same as K192363 and
K191513.
Carrier Phase:
Same as K191513. |
| Physical
Structure | Granules with a
natural,
interconnected, porous
structure which
mimics the natural
structure of bone. | Granules with a
porosity similar to
cancellous bone | Granules with a
porosity similar to
cancellous bone | Same as K191513,
K192363, and
K140375. |
| Nominal
(Total)
Porosity | 80% (interconnected
porosity) | 82.5 ± 2.5% | 82.5 ± 2.5% | Same as K191513,
K192363, and
K140375. |
| Strut
Porosity | Information not
publicly disclosed. | 31-47% | 31-47% | Same as K191513
K192363. |
| Sterility | Sterile, single use | Sterile, single use | Sterile, single use | Same as K191513,
K192363, and
K140375. |
| Sterilization
Method | Irradiation | Irradiation | Irradiation | Same as K191513,
K192363, and
K140375. |
Table 3. Technological Characteristics
DISCUSSION OF NONCLINICAL TESTS
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results met the acceptance criteria, and support that the proposed devices are appropriately designed for their intended use.
Sterility
The ALTAPORE SHAPE device is sterilized with radiation. The minimum sterilizing dose (MSD) required to provide a 10-6 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in
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Image /page/7/Picture/1 description: The image shows the word "Baxter" in a bold, italicized font. The word is in a dark gray color, and the background is white. The font is sans-serif and appears to be a company logo.
ANSI/AAMI/ISO 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
Stability indicating parameters are identical to those previously cleared under the ALTAPORE SHAPE premarket notification K191513. A shelf life claim of 5 years is substantiated by stability results presented under K191513.
Performance Testing- Bench
The proposed device is identical to the ALTAPORE SHAPE predicate device cleared under K191513. As such, no additional bench testing was conducted. All previous verification and validation testing performed for the ALTAPORE SHAPE predicate device, cleared under K191513, are applicable to the proposed product.
The following in vitro studies were conducted as part of the predicate submission to evaluate the performance characteristics of ALTAPORE SHAPE:
- . Bioactive properties
Performance Testing- Animal
A preclinical animal study was conducted to evaluate the following performance characteristics of ALTAPORE SHAPE for use in posterolateral spine fusion procedures as a bone graft extender. This study is presented again to support the performance of ALTAPORE SHAPE as a stand-alone graft substitute in posterolateral spinal fusion procedures:
- Effectiveness for use in posterolateral fusion
Biocompatibility
There are no changes to ALTAPORE SHAPE compared to the predicate device submission K191513. A summary of testing previously cleared under K191513 is included.
Biocompatibility assessments were conducted based on ISO-10993-1 and FDA guidance Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices
8
K200640 axter
Part 1: Evaluation and Testing within a Risk Management Process," as recommended in the FDA guidance document, Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation ●
- System Toxicity ●
- Pyrogen
- Genotoxicity
- Implantation
CONCLUSION
The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed for the same intended use.