ALTAPORE SHAPE must be used in combination with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

Device Description

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Altapore Shape device, a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate and reference devices, outlining the device's composition, intended use, and nonclinical testing.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical study with primary endpoints. Instead, the "acceptance criteria" are implied by the various nonclinical tests performed to demonstrate substantial equivalence to legally marketed predicate devices. The "reported device performance" is the conclusion that the device met these implied criteria, making it substantially equivalent.

Acceptance Criteria (Implied)	Reported Device Performance
Sterility: Achieve a 10-6 Sterility Assurance Level (SAL) via radiation sterilization. Package integrity maintained.	Sterility: The device is sterilized with radiation, and the minimum sterilizing dose (MSD) for a 10-6 SAL was established and validated as described in ANSI/AAMI/ISO ISO 11137-2. Package Verification testing (Visual Inspection, Seal Strength, Bubble Leak testing) supports sterility.
Shelf Life: Maintain stability and performance over time, ideally matching or exceeding predicate/reference devices.	Shelf Life: A shelf life claim of 5 years is substantiated by stability results of the reference device ACTIFUSE SHAPE (K082575), as stability-indicating parameters are identical due to shared materials and packaging.
Performance - Bench: Demonstrate bioactive and osteoconductive properties, and similar physical structure/porosity to predicate.	Performance - Bench: No additional bench testing was conducted as the microgranule phase has identical chemical composition, physical structure, and manufacturing process to the predicate (K181225), and the carrier phase is identical to the reference device (K082575). Previous verification/validation testing for K181225 and K082575 are considered applicable. In vitro studies from the predicate submission evaluated bioactive properties (forming a surface apatite-layer in simulated body fluid).
Performance - Animal (Effectiveness): Demonstrate effectiveness for use in posterolateral fusion and extremities.	Performance - Animal: A preclinical animal study evaluated effectiveness for use in posterolateral fusion (with autogenous iliac crest bone graft (ICBG)). Another preclinical animal study assessed effectiveness for use in extremities (with and without autologous blood). The text states that "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."
Biocompatibility: Meet ISO-10993-1 and FDA guidance recommendations for biological safety.	Biocompatibility: Assessments were conducted based on ISO-10993-1 and FDA guidance. Testing included Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogen, Genotoxicity, and Implantation. The components of Altapore Shape (hydroxyapatite microgranule and alkylene oxide copolymer carrier) have been used in previously cleared predicate/reference devices with the same intended use and contact duration.
Substantial Equivalence: All non-clinical data demonstrates the device is substantially equivalent to predicates.	Substantial Equivalence: The non-clinical data demonstrates that the subject device is substantially equivalent and performs comparably to the predicate and reference devices for the same intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to preclinical animal studies for performance testing. However, it does not provide details on the sample size for these animal studies.
The provenance of the data (e.g., country of origin) is also not specified. The studies appear to be prospective in nature, as they were conducted to evaluate the device's performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The animal studies involved radiographic, histopathological, histomorphometric, and mechanical analyses, which would typically involve expert interpretation. However, the number and qualifications of these experts are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication methods for the test set. Animal study results would typically be analyzed by the study researchers.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document describes the clearance of a medical implant (bone void filler), not an AI-powered diagnostic or assistive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. As stated above, this is an implantable medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the animal performance studies, the "ground truth" (or evidence of performance) was established through:

Radiographic analyses
Histolopathological analyses
Histomorphometric analyses
Mechanical analyses

These are objective measures of bone healing and integration in animal models.

For biocompatibility, the ground truth was based on the results of the specified in vitro and in vivo tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogen, Genotoxicity, Implantation) as per ISO-10993-1 and FDA guidance.

8. The sample size for the training set

The document does not mention a "training set" as it pertains to AI/ML development. This is a traditional medical device submission based on substantial equivalence to existing devices and nonclinical testing.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of an AI/ML training set in the document.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Baxter Healthcare Corporation Phillip Romei Specialist, Global Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073

Re: K191513

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: September 16, 2019 Received: September 18, 2019

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

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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,

Laurence D. Coyne, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K191513

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, pelvis and posterolateral spine).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5. 510(k) Summary

October 17, 2019

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Phillip Romei Specialist, Regulatory Affairs 32650 N Wilson Road 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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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 HealthcareCorporation	K181225	August 31, 2018
ACTIFUSE SHAPE(Reference Device)	Baxter HealthcareCorporation	K082575	November 25, 2018
MASTERGRAFT® Putty(Predicate Device)	Medtronic Sofamor DanekUSA, Inc.	K140375	April 18, 2014

Table 2. Predicate and Reference Devices

DESCRIPTION OF THE DEVICE:

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,

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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, pelvis and posterolateral spine).

PURPOSE OF SUBMISSION

The purpose of this submission is to introduce the ALTAPORE SHAPE bone void filler to the market. The proposed device is a suspension of ALTAPORE microgranules currently used in Baxter's ALTAPORE Bone Graft substitute product lines, previously cleared under 510(k) premarket notifications K181225, in the alkylene oxide copolymer carrier currently used in Baxter's ACTIFUSE SHAPE bone graft substitute, previously cleared under 510(k) premarket notification K082575. The hydroxyapatite granules used in ALTAPORE SHAPE, ALTAPORE, and ACTIFUSE SHAPE are all chemically identical. The intended use of the proposed product is the same as the predicate and reference device, and the fundamental technology of the device is the same across all three devices.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

ALTAPORE SHAPE is substantially equivalent to the predicate device previously cleared under 510(k) premarket notification, K181225 and the reference devices cleared under 510(k) premarket notifications K082575 and K140375. The function and intended use of the proposed device are equivalent to the predicate and reference devices. Table 3 provides a comparison of the technological characteristics of the proposed and predicate devices.

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	Predicate Device(K140375):	Reference Device(K082575):	Predicate Device(K181225):	Proposed Device:
Features	MASTERGRAFT® Putty	ACTIFUSESHAPE	ALTAPORE	ALTAPORESHAPE
Composition	Calcium PhosphateSalt:Purified collagenof bovine origin andbiphasic calciumphosphate ceramic.Type I bovinecollagen.15 percenthydroxyapatite and85 percent β-tricalciumphosphateformulation.	Calcium PhosphateSalt:Silicate-substitutedcalcium phosphatecomposed solely ofelements that existnaturally in normalbone (Ca, P, O, H,Si).	Calcium PhosphateSalt:Silicate-substitutedcalcium phosphatecomposed solely ofelements that existnaturally in normalbone (Ca, P, O, H,Si).	Identical toAltapore predicatedevice andACTIFUSESHAPE refrencedevice.
PhysicalStructure	Granules with anatural,interconnected,porous structurewhich mimics thenatural structure ofbone.	Granules with anatural,interconnected,porous structurewhich mimics thenatural structure ofbone.	Granules with aporosity similar tocancellous bone.	Identical toAltapore (predicate)and Actifuse Shape(reference device).
Nominal(Total)Porosity	80%(interconnectedporosity)	80 ± 2.5%	82.5 ± 2.5%	Identical toAltapore (predicate)and Actifuse Shape(reference device).
StrutPorosity	Information notpublicly available.	Microporous	31-47%	Identical toAltapore(predicate).
Sterility	Irradiation	Irradiation	Irradiation	Identical toAltapore (predicate)and Actifuse Shape(reference device).

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.

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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 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 between the reference device ACTIFUSE SHAPE and ALTAPORE SHAPE. as both are composed of the same materials and have identical packaging materials. A shelf life claim of 5 years is substantiated by stability results of the reference device ACTIFUSE SHAPE, (cleared under K082575).

Performance Testing- Bench

The microgranule phase of the proposed device and predicate device has identical chemical composition, physical structure, and manufacturing process and the carrier phase of the proposed device is identical to the chemical composition, packaging and sterilization methods . As such, no additional bench testing was conducted. All previous verification and validation testing performed for the predicate device, cleared under K181225, and testing performed for the ACTIFUSE SHAPE reference device, cleared under K082575, 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 the spine:

Effectiveness for use in posterolateral fusion (with autogenous iliac crest bone graft (ICBG))

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A preclinical animal study was carried out to assess the following performance characteristics of ALTAPORE SHAPE in extremities:

Effectiveness for use in extremities (with and without autologous blood))

Biocompatibility

The hydroxyapatite microgranule phase in the proposed device has been used in the predicate device, ALTAPORE, with the same intended use and with the same type and duration of contact. ALTAPORE has been previously cleared under 510(k) submission, K181225.

The alkylene oxide copolymer carrier phase in the proposed device has previously been used in the reference device. ACTIFUSE SHAPE, with the same intended use and with the same type and duration of contact. ACTIFUSE SHAPE has been previously cleared under 510(k) submission, K082575.

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

CONCLUSION

The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device and reference devices that are currently marketed for the same intended use.

Regulation Number and Section

§ 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.