Device 300397 Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Device 300397 Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, ilium and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device 300397 Putty must be used with blood or autogenous bone marrow aspirate and autograff in posterolateral spine.

Device Description

Device 300397 Putty is an osteoconductive, porous, resorbable bone graft substitute which consists of calcium phosphate granules (a-TCP and hydroxyapatite) and Type I and III porcine collagen. The single-patient, single-use product is supplied in three (3) sizes as a sterile, dry block. When mixed with autogenous bone marrow aspirate, blood or sterile non-pyrogenic saline, the product forms a moldable non-setting putty (net volume: 2.5 cc, 5 cc or 10 cc).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Device 300397 Putty), which is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed clinical study with acceptance criteria, sample sizes, and ground truth establishment in the way typically seen for a novel diagnostic or AI device.

Therefore, the requested information components related to acceptance criteria, specific study design for proving acceptance criteria for an AI/diagnostic device, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance metrics are not applicable to this document.

This document describes a device approval process based on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and performance through various tests, primarily non-clinical, not a study designed to meet specific performance metrics against a defined ground truth for a diagnostic outcome.

However, I can extract information regarding the safety and performance studies that were conducted to support the substantial equivalence claim.

Here's a summary based on the provided document, addressing the closest relevant points:

1. Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in the manner of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implicitly met by successful execution and favorable results of the numerous safety and performance tests to demonstrate substantial equivalence to the predicate device. The "reported device performance" is described qualitatively through these tests.

Category	Specific Test	Description of Performance (Implicitly Meets Acceptance)
Chemical Properties	Amino Acid Composition, Product Composition, Phase Analysis, FT-IR, SEM, Molecular Weight Distribution, Onset Temperature and Enthalpy of Protein Denaturation, Enzymatic Collagen Degradation	The device components (calcium phosphate granules, porcine collagen) were characterized. The use of a different TCP polymorph compared to the predicate was deemed not to raise different safety/effectiveness concerns due to similar structural composition and chemical stoichiometry. Identified raw material sources for porcine collagen were previously cleared.
Physical Properties	Pore Size and Pore Size Distribution, Particle Size Distribution, Weight, Dimension, and Density, Determination of Hydrated Volume	Granule size is slightly larger than the predicate but demonstrated through performance testing not to raise new concerns.
Material Handling	N/A (Studies Conducted)	N/A
Sterilization	ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2017	Validation successfully executed.
Packaging	ISO 11607-1:2019, ASTM F1980:2007, ASTM F1886/F1886M:2016, ASTM F88:2015, ASTM F1929:2015, and ASTM F2096:2011	Validation successfully executed.
Product Stability	ICH Q1A(R2)	N/A (Studies Conducted)
Transport Simulation	ISTA 3A	N/A (Studies Conducted)
Biocompatibility	ISO 10993-1:2018 (comprising Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute Systemic Toxicity, Subchronic Systemic Toxicity, Genotoxicity, Implantation (local tissue reaction), Hemocompatibility, Chronic Systemic Toxicity, Elemental Impurities Analysis)	Successfully executed. Local tissue reaction was evaluated in accordance with ISO 10993-6:2016.
In Vivo Performance	NZ White Rabbit Single Level Spinal Fusion Model	Device 300397 Putty hydrated with BMA or blood and mixed 1:1 with autograft demonstrated: - Progression in healing vs. time when implanted on decorticated transverse processes in the posterolateral space. - Further healing at host decorticated transverse process interfaces with new bone formation and active osteoblasts. - New bone formation directly on the graft material surfaces. - Confirmed progression and maturation of fusions via histology. - Bone remodeling and new marrow spaces at the decorticated host transverse process interface, with an association with a reduction in local inflammatory cells. Performance evaluated per FDA guidance for calcium salt bone void fillers.

2. Sample Size and Data Provenance (for test set for AI/diagnostic devices):

Not applicable for this 510(k) submission as it's not an AI/diagnostic device.
For the in vivo animal study, the model used was the NZ White Rabbit Single Level Spinal Fusion Model. The specific number of animals is not provided in this summary. This is a prospective animal model study.

3. Number of Experts and Qualifications (for ground truth for AI/diagnostic devices):

Not applicable as there is no mention of establishing ground truth by human experts for a diagnostic task.
The evaluation of the in vivo study results (e.g., histology interpretation, assessment of bone formation) would typically be performed by veterinary pathologists or experts in orthopedics/bone regeneration, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method (for test set for AI/diagnostic devices):

Not applicable for this type of device and submission.

5. MRMC Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study for human readers with and without AI assistance was not done, as this is not an AI/diagnostic device.

6. Standalone Performance Study:

No, a standalone algorithm-only performance study was not done, as this is not an AI/diagnostic device.
The "standalone" performance for this device is represented by the in vivo animal study where the device's ability to promote bone healing was directly assessed.

7. Type of Ground Truth Used:

For the in vivo animal study, the "ground truth" for assessing bone healing and tissue reaction was based on histology (microscopic examination of tissue samples) and observation of fusion progression in the animal model. This could be considered similar to "pathology" for human studies, reflecting direct biological evidence of effect.

8. Sample Size for Training Set:

Not applicable as this is not an AI/machine learning device that requires a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable as this is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 8th, 2024

Geistlich Pharma AG % Roshana Ahmed Sr. Regulatory Specialist TELOS Partners LLC 2850 Frontier Drive Warsaw, Indiana 46582

Re: K241802

Trade/Device Name: Device 300397 Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV Dated: October 4, 2024 Received: October 4, 2024

Dear Roshana Ahmed:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

Robert M. Stefani -S 2024.11.08 12:42:36 -05'00'

For: Jesse Muir, Ph.D. 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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Indications for Use

Submission Number (if known)

K241802

Device Name

Device 300397 Putty

Indications for Use (Describe)

Device 300397 Putty must be used with blood or autogenous bone marrow aspirate and autograff in 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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510(k) Summary

I. Submitter

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55

Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: November 1, 2024

II. Device

Device Proprietary Name:	Device 300397 Putty
Common or Usual Name:	Bone Void Filler
Classification Name:	Filler, Bone Void, Calcium Compound
Regulation Number:	CFR 888.3045
Product Code:	MQV
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

MASTERGRAFT® Putty, K071813, Medtronic Sofamor Danek ●
The following reference devices are cited within the submission:
Actifuse ABX E-Z-fil Bone Graft Substitute, K081979, ApaTech Limited
OsteoFlo® NanoPutty® Quadphasic Synthetic Bone Graft, K200064, SurGen Tec LLC ●
Geistlich Bio-Gide, K192042, Geistlich Pharma AG

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IV. Device Description

Device 300397 Putty is an osteoconductive, porous, resorbable bone graft substitute which consists of calcium phosphate granules (α-ΤCP and hydroxyapatite) and Type I and III porcine collagen. The single-patient, single-use product is supplied in three (3) sizes as a sterile, dry block. When mixed with autogenous bone marrow aspirate, blood or sterile non-pyrogenic saline, the product forms a moldable non-setting putty (net volume: 2.5 cc, 5 cc or 10 cc).

Indications for Use V.

Device 300397 Putty must be used with blood or autogenous bone marrow aspirate and autograft in posterolateral spine.

VI. Comparison of Technological Characteristics

Device 300397 Putty is substantially equivalent to the predicate device in terms of intended use and technological characteristics. There are slight differences between the subject and predicate device with respect to the indications for use statement; however, these differences do not alter the overall intended use of the subject device. Both devices are resorbable bone void fillers intended to fill bony voids or gaps of the skeletal system that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Device 300397 Putty and the predicate device are osteoconductive materials which utilize the same ratio of inorganic to organic material, are sterilized via irradiation, and are biologically safe. The subject device consists of calcium phosphate granules and porcine collagen. The calcium phosphate granules (0.5 - 2 mm) are comprised of a synthetic, porous, biphasic a-TCP/hydroxyapatite material. The use of a different TCP polymorph in the subject device does not raise different questions of safety and effectiveness as the polymorphs share the same structural composition (i.e., the crystal structures are similar and have almost identical unit cell size and volume) and chemical stoichiometry.

The porcine collagen utilized in Device 300397 Putty is used in Geistlich Pharma AG's dental products and the identified raw material sources were previously cleared by the FDA.

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The granule size for Device 300397 Putty is slightly larger than that of the predicate device; however, as demonstrated through performance testing, there are no new or different concerns raised by the larger size.

As seen above. Device 300397 Putty is the same or similar to the predicate device in terms of intended use, sterilization and biological safety profile. The technological differences between the subject and predicate device do not raise new questions of safety and effectiveness and the data provided within this submission support that Device 300397 Putty is substantially equivalent to the identified predicate device.

Safety & Performance Data VII.

The following studies were successfully executed.

Characterization of chemical properties ●
- 0 Amino Acid Composition
- Product composition (Residue on ignition) o
- Phase Analysis by X Ray Diffraction O
- Characterization by FT-IR O
- SEM O
- Molecular Weight Distribution of Soluble Protein o
- Onset Temperature and Enthalpy of Protein Denaturation by Differential O Scanning Calorimetry
- Enzymatic Collagen Degradation o
Characterization of physical properties ●
- Pore Size and Pore Size Distribution O
- Particle Size Distribution O
- Weight, Dimension, and Density O
- o Determination of Hydrated Volume
Material Handling Studies ●
. Sterilization Validation per ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2017
Packaging Validation per ISO 11607-1:2019, ASTM F1980:2007, ASTM . F1886/F1886M:2016, ASTM F88:2015, ASTM F1929:2015, and ASTM F2096:2011
Product stability testing per ICH Q1A(R2) ●
Transport Simulation per ISTA 3A
Biocompatibility Studies per ISO 10993-1:2018 ●
- Cytotoxicity per ISO 10993-5:2009 O
- O Sensitization per ISO 10993-10:2010

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Irritation/Intracutaneous Reactivity per ISO 10993-10:2010 O
Acute Systemic Toxicity per ISO 10993-11:2017 O
Material Mediated Pyrogenicity per USP <151> / Ph. Eur. Section 2.6.8 o
Subacute Systemic Toxicity per ISO 10993-6:2016 and ISO 10993-11:2017 O
Subchronic Systemic Toxicity per ISO 10993-6:2016 and ISO 10993-11:2017 O
Genotoxicity per ISO 10993-3:2014 O
Implantation (local tissue reaction) per ISO 10993-6:2016 o
Hemocompatibility per ASTM F756:2017 and ISO 10993-4:2017 O
Chronic Systemic Toxicity per ISO 10993-11:2017 O
Elemental Impurities Analysis ICH Q3D (R2):2022 O

In addition, the safety and performance of Device 300397 Putty was evaluated as a bone graft extender in the NZ White Rabbit Single Level Spinal Fusion Model. The performance of the device was evaluated in accordance with the requirements of the FDA guidance on calcium salt bone void filler guidance while the local tissue reaction was evaluated in accordance with the requirements of ISO 10993-6:2016.

Device 300397 Putty was hydrated with bone marrow aspirate (BMA) or with blood and mixed 1:1 with autograft; the predicate device was hydrated with BMA and mixed 1:1 with autograft. The graft material was placed adjacent to the vertebral body as well as between decorticated transverse processes. Progression in healing versus time was observed when implanted on decorticated transverse processes in the posterolateral space. Further healing was observed at the host decorticated transverse process interfaces with new bone formation with active osteoblasts present directly on the surface of the graft material and autograft material. New bone formation directly on the surfaces of graft material and autograft was also observed. The progression and maturation of the fusions treated with Device 300397 Putty hydrated with BMA or blood were confirmed via histology. Bone remodeling and formation of new marrow spaces was seen at the decorticated host transverse process interface as new bone formation on and through the graft material which was associated with a reduction in local inflammatory cells.

VIII. Conclusion

The information provided above supports that Device 300397 Putty is as safe and effective as the predicate device. Although minor differences in design and technology exist between the subject and predicate device, performance testing demonstrates that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that Device 300397 Putty is substantially equivalent to the predicate device.

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.