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.

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, which is a resorbable calcium salt bone void filler. The submission focuses on aligning the indications for use of Altapore Shape for posterolateral spinal fusion procedures with a previously cleared predicate device, Altapore (K192363).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results for this submission (K200640). Instead, it relies on the substantial equivalence to previously cleared predicate devices. The key "performance criterion" for this submission is demonstrating that the change in indications (specifically referring to its use in posterolateral spinal fusion as a stand-alone graft) does not alter the safety and effectiveness, leveraging prior studies.

However, the document mentions that for the initial clearance of Altapore Shape (K191513) and Altapore (K192363), various tests were conducted and met acceptance criteria. Based on the provided text, the relevant performance characteristics and implicitly met acceptance criteria are:

Acceptance Criteria (Implied)	Reported Device Performance (Reference to K191513 and K192363)
Sterility: Achieve a 10-6 Sterility Assurance Level (SAL).	Established and validated at the manufacturing facility as described in ANSI/AAMI/ISO ISO 11137-2. Labels "Sterile". Package verification based on Visual Inspection, Seal Strength, and Bubble Leak testing.
Shelf Life: Maintain stability over time.	A shelf life claim of 5 years is substantiated by stability results presented under K191513.
Bioactivity: Forms a surface apatite-layer.	Bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid (contains same ion concentrations as human blood plasma).
Osteoconductivity and Bone Healing: Supports bone growth and is replaced by natural bone in a critical defect model.	Osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model, confirmed with radiographic, histopathologic, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone. This was demonstrated for Altapore Shape (K191513) and for Altapore (K192363) for posterolateral spine fusion, and these findings are leveraged here.
Biocompatibility: No adverse biological reactions.	Biocompatibility assessments (Cytotoxicity, Sensitization, Irritation, System Toxicity, Pyrogen, Genotoxicity, Implantation) were conducted based on ISO-10993-1 and FDA guidance for K191513 and are unchanged.
(For this submission) Equivalence of Posterolateral Spine Fusion Indication: Safe and effective for stand-alone use in posterolateral spinal fusion.	The preclinical animal study conducted for Altapore (K192363) on posterolateral spine fusion, which demonstrated effectiveness as a bone graft extender, is "presented again to support the performance of ALTAPORE SHAPE as a stand-alone graft substitute in posterolateral spinal fusion procedures." The hydroxyapatite granules are identical to ALTAPORE, and carrier phase differences do not alter therapeutic use or safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of this 510(k) submission (K200640) for human clinical trials. The submission focuses on leveraging previous substantial equivalence.

Animal Studies: A preclinical animal study was conducted to evaluate the effectiveness of Altapore (or similar material) for posterolateral spinal fusion. The sample size for this animal study is not specified in the provided text. The data provenance would be prospective (animal study) from wherever the animal studies were conducted (country of origin not specified).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the text. For animal studies, the "ground truth" (e.g., bone healing confirmation) would typically be established by veterinary pathologists or histomorphometrists.

4. Adjudication Method

This information is not provided in the text. For animal studies, typically, the assessment of outcomes (e.g., histopathology, radiological findings) is performed by qualified individuals, but a formal "adjudication method" like 2+1 or 3+1 among experts is usually not described in such summaries unless there's a specific need for it in complex interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied in the provided text. This type of study is more common for diagnostic AI devices, not directly for a bone void filler material itself, especially in a 510(k) submission focused on material equivalence and a slight indication expansion based on prior animal data.

6. Standalone Performance Study

Yes, a standalone performance evaluation was done through the preclinical animal study and the in vitro studies.

In vitro studies: Demonstrated bioactive properties (apatite layer formation).
Animal study: Evaluated effectiveness for use in posterolateral fusion. This study directly assessed the material's ability to achieve bone healing. While the exact details of how "performance" was measured (e.g., fusion rates, bone density) are not given, the study was conducted on the device material itself.

7. Type of Ground Truth Used

For the animal studies mentioned:

Histopathology: Assessing tissue changes at a microscopic level.
Histomorphometry: Quantitative analysis of tissue structure (e.g., amount of new bone formation).
Radiographic analysis: Imaging techniques to visualize bone healing.
Mechanical analyses: Testing the strength of the healed bone segment.

These methods collectively served as the "ground truth" to determine bone healing and fusion in the animal model.

8. Sample Size for the Training Set

The document does not mention a training set. This is because Altapore Shape is a medical device (a material), not an AI algorithm that requires a training set for model development. The performance is based on its material properties and biological interactions demonstrated in non-clinical studies.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set (relevant for AI), this question is not applicable.

Summary

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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

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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,

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

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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 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).

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)

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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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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	K192363	January 09, 2020
ALTAPORE SHAPE(Predicate Device)	Baxter HealthcareCorporation	K191513	October 19, 2019
MASTERGRAFT® Putty(Predicate Device)	Medtronic Sofamor DanekUSA, Inc.	K140375	April 18, 2014

Table 2. Predicate 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, 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):ALTAPORESHAPE	Predicate Device(K192363):ALTAPORE	Proposed Device:ALTAPORESHAPE
ChemicalComposition	Calcium PhosphateSalt:Purified collagen ofbovine origin andbiphasic calciumphosphate ceramic.Type I bovinecollagen.15 percenthydroxyapatite and 85percent ß-tricalciumphosphate formulation.	Calcium PhosphateSalt phase:Phase-pure silicon-substitutedhydroxylapatite$Ca10(PO4)(6-x)(SiO4)(x)(OH)(2-X)$Silicon is present in0.8 wt% amounts.Carrier:Absorbable AlkyleneOxide Co-polymer	Calcium PhosphateSalt phase:Phase-pure silicon-substitutedhydroxylapatite$Ca10(PO4)(6-x)(SiO4)(x)(OH)(2-X)$Silicon is present in0.8 wt% amounts.Carrier:Absorbable AqueousGel	Calcium PhosphateSalt phase:Same as K192363 andK191513.Carrier Phase:Same as K191513.
PhysicalStructure	Granules with anatural,interconnected, porousstructure whichmimics the naturalstructure of bone.	Granules with aporosity similar tocancellous bone	Granules with aporosity similar tocancellous bone	Same as K191513,K192363, andK140375.
Nominal(Total)Porosity	80% (interconnectedporosity)	82.5 ± 2.5%	82.5 ± 2.5%	Same as K191513,K192363, andK140375.
StrutPorosity	Information notpublicly disclosed.	31-47%	31-47%	Same as K191513 K192363.
Sterility	Sterile, single use	Sterile, single use	Sterile, single use	Same as K191513,K192363, andK140375.
SterilizationMethod	Irradiation	Irradiation	Irradiation	Same as K191513,K192363, andK140375.

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

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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.

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.