K Number
K190814
Device Name
AccuFill Bone Substitute Material
Date Cleared
2019-06-10

(73 days)

Product Code
Regulation Number
888.3045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AccuFill Bone Substitute Material is an injectable, seff-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Device Description
AccuFill Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration fluid and mixed. Once mixed, the resulting paste is used to fill osseous defects. The paste can be administered to the treatment site by injection or by manual application. AccuFill hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite ("PCHA"), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. AccuFill is an osteoconductive material that is resorbed and replaced by natural bone over time. AccuFill BSM is available in two packaging configurations: (1) AccuFill BSM is sold in a jar and can be mixed in a bowl or mixing syringe; (2) AccuFill BSM is also sold in a prefilled mixing syringe. AccuFill BSM is delivered to the osseous defect site with stainless steel AccuPort cannulas.
More Information

BK100027

No
The description focuses on the material properties and physical application of a bone graft substitute, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is described as a "bone graft substitute material" intended to "fill bony voids or gaps of the skeletal system" and resorbs and is "replaced with new bone during the healing process," indicating its therapeutic purpose in promoting bone regeneration.

No
The device is a bone graft substitute material intended to fill bony voids, not diagnose conditions.

No

The device description clearly outlines a physical bone substitute material (powder and hydration fluid) and delivery components (jar, mixing syringe, cannulas). This is a hardware-based medical device, not software-only.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that AccuFill Bone Substitute Material is used to fill bony voids or gaps in the skeletal system. This is a therapeutic or structural application within the body.
  • Device Description: The description details a material that is mixed and applied to a surgical site to harden and be replaced by bone. This is a direct interaction with the patient's tissue.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used outside the body to analyze samples and provide diagnostic information. AccuFill is a material implanted within the body for structural support and bone regeneration.

N/A

Intended Use / Indications for Use

AccuFill Bone Substitute Material is an injectable, self-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Product codes

MOV, FMF

Device Description

AccuFill Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration fluid and mixed. Once mixed, the resulting paste is used to fill osseous defects. The paste can be administered to the treatment site by injection or by manual application. AccuFill hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite ("PCHA"), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. AccuFill is an osteoconductive material that is resorbed and replaced by natural bone over time.

AccuFill BSM is available in two packaging configurations: (1) AccuFill BSM is sold in a jar and can be mixed in a bowl or mixing syringe; (2) AccuFill BSM is also sold in a prefilled mixing syringe. AccuFill BSM is delivered to the osseous defect site with stainless steel AccuPort cannulas.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The following performance testing was performed:

  • Simulated Use/Extrusion Testing
  • Working Time
  • Setting Time
  • Compression Strength
  • Biocompatibility Evaluation
  • Bacterial Endotoxin Test (BET) to establish that the device meets pyrogen limit specifications
  • Sterility Validation Testing
  • Shelf-Life and Packaging Validation Testing

Key Metrics

Not Found

Predicate Device(s)

OssiPro (ETEX Corp., K062630), CarriGen® Porous Bone Substitute Material (ETEX Corp., K093447 and K101557), and CarriGen PF (ETEX Corp., K182107)

Reference Device(s)

BioCUE bone marrow aspiration needle (BK100027)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

0

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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer Knee Creations % Hollace Saas Rhodes Vice President, Orthopedic Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K190814

Trade/Device Name: AccuFill Bone Substitute Material Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, FMF Dated: March 29, 2019 Received: March 29, 2019

Dear Ms. Rhodes:

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.

1

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 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 (QS) 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 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-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. 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

Indications for Use

510(k) Number (if known) K190814

Device Name AccuFill Bone Substitute Material

Indications for Use (Describe)

AccuFill Bone Substitute Material is an injectable, seff-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

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)Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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."

3

K190814 Date received: March 29, 2019

510(k) Summary

| Manufacturer: | ETEX Corporation
55 Messina Drive
Braintree, MA 02184 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. David L. Nichols
Vice President, General Manager
Zimmer Knee Creations
841 Springdale Drive
Exton, PA 19341
Phone: 484.887.8902
david.nichols@zimmerbiomet.com |
| Prepared By: | MCRA, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | May 31, 2019 |
| Device Trade Name: | AccuFill Bone Substitute Material |
| Common Names: | Bone void filler
Piston Syringe |
| Regulations: | 21 CFR 888.3045 – Resorbable calcium salt bone void filler device
21 CFR 880.5680 – Piston syringe |
| Classification: | Class II |
| Product Codes: | MQV, FMF |

Indications for Use:

AccuFill Bone Substitute Material is an injectable, self-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e., posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Description:

AccuFill Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of hydration fluid and mixed. Once mixed, the resulting paste is used to fill osseous defects. The paste can be administered to the treatment site by injection or by manual application. AccuFill hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly

4

K190814 Page 2 of 2

crystalline hydroxyapatite ("PCHA"), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. AccuFill is an osteoconductive material that is resorbed and replaced by natural bone over time.

AccuFill BSM is available in two packaging configurations: (1) AccuFill BSM is sold in a jar and can be mixed in a bowl or mixing syringe; (2) AccuFill BSM is also sold in a prefilled mixing syringe. AccuFill BSM is delivered to the osseous defect site with stainless steel AccuPort cannulas.

Predicate and Reference Devices:

OssiPro (ETEX Corp., K062630), CarriGen® Porous Bone Substitute Material (ETEX Corp., K093447 and K101557), and CarriGen PF (ETEX Corp., K182107) serve as predicates. The BioCUE bone marrow aspiration needle (BK100027) serves as a reference device.

Performance Testing:

All necessary testing has been performed to assure the substantial equivalence of AccuFill to the predicate devices, and demonstrate the device performs as intended.

The following performance testing was performed:

  • Simulated Use/Extrusion Testing ●
  • Working Time ●
  • Setting Time
  • Compression Strength
  • Biocompatibility Evaluation
  • Bacterial Endotoxin Test (BET) to establish that the device meets pyrogen limit specifications
  • Sterility Validation Testing
  • Shelf-Life and Packaging Validation Testing

Substantial Equivalence:

AccuFill Bone Substitute Material is substantially equivalent to the predicate devices based on indications for use, technological characteristics, design, material, mechanical performance testing, method of application, packaging and sterilization. Predicate devices K062630, K093447 and K101557 are synthetic calcium phosphate bone graft subject device's chemical composition and manufacturing processes are identical to those of the predicate bone substitute material. When AccuFill is prefilled in a mixing syringe, it is identical to CarriGen PF cleared in K182107. Subchondroplasty (i.e., the filling of subchondral osseous defects with AccuFill) is within the scope of the cleared indications for use of the identified predicates (i.e., CarriGen, K093447 and K101557; and CarriGen PF, K182107). AccuFill is identical to these predicates with respect to its indications for use in (e.g., filling osseous defects in the extremities) and is subject to the stipulations included within the warnings and precautions in the device's labeling. The AccuPort cannulas are substantially equivalent to the needles used for delivery of CarriGen to an osseous defect.