K Number
K132470
Device Name
SOLUM IV BONE VOID FILLER
Date Cleared
2014-05-21

(287 days)

Product Code
Regulation Number
888.3045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow aspirate. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Device Description
Solum IV ® is a resorbable porous calcium phosphate bone void filler mixed with a porcine gelatin based carrier. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone.It is provided sterile in various configurations within a double sealed package containing a mixing spatula.
More Information

Not Found

No
The 510(k) summary describes a bone void filler material and its physical properties and performance in animal studies. There is no mention of AI, ML, image processing, or any computational analysis of data.

Yes
The device is described as a bone void filler that resorbs and is replaced by the growth of new bone during the healing process, which is a therapeutic action.

No
The device description and intended use clearly state that Solum IV is a bone void filler intended to facilitate bone growth and repair, not to identify or diagnose conditions.

No

The device description clearly states it is a physical product: "Solum IV ® is a resorbable porous calcium phosphate bone void filler mixed with a porcine gelatin based carrier." It is provided sterile in packaging with a mixing spatula. This is a hardware device, not software.

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 Solum IV is a bone void filler intended to be packed into bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
  • Device Description: The description details a resorbable porous calcium phosphate bone void filler mixed with a carrier. This is a material designed to be implanted in the body, not a reagent or instrument used to examine specimens from the body.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.

IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Solum IV does not fit this description.

N/A

Intended Use / Indications for Use

Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow aspirate. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Product codes (comma separated list FDA assigned to the subject device)

MQV

Device Description

Solum IV ® is a resorbable porous calcium phosphate bone void filler mixed with a porcine gelatin based carrier. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone.It is provided sterile in various configurations within a double sealed package containing a mixing spatula.
Solum IV ® is composed of porous hydroaxyapatite granules and a Type A porcine gelatin based carrier. The granules consist of macroporous ceramic granules composed of greater than 95% hydroxyapatite (HAp). The calcium phosphate granuals are presented as ground particles. The macroporous sturcture of Solum IV provides a resorbable osteoconductive scaffold.

The gelatin based carrier is presented as ground freeze-dried particles. The product forms a cohesive and adhesive dough with a putty-like consistency upon hydration which allows the shape of the implant to conform to the defect maximizing direct contact with viable host 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 and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Solum IV and/or its components have undergone non-clinical testing including chemical. physical, animal, component biocompatibility, and handling characteristics. A critically sized defect implantation animal study demonstrated that Solum IV performed as well as the predicate device. Testing has provided a reasonable assurance of safety and effectiveness for its intended use with respect to the predicate device and supports a determination of substantial equivalence to the predicate device.

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.

K081558

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.

0

MAY 2 1 2014 SpineSmith Solum IV ® Bone Void Filler, Bone Graft Substitute

510(k) Summary of Safety and Effectiveness
SUBMITTED BYSpineSmith Partners, LLP
93 Red River
Austin, TX 78701
ESTABLISHMENT
REGISTRATION NUMBER3006404071
CONTACT PERSONClifton (Chris) Naivar
Director - Quality and Regulatory Affairs
Phone: 512-637-2068
Fax: 512-637-2096
Email: cnaivar@spinesmithusa.com
SUBMISSION PREPARED BYClifton (Chris) Naivar
Director - Quality and Regulatory Affairs
Phone: 512-637-2068
DATE PREPAREDMay 14, 2014
CLASSIFICATIONClass II
MQV - Resorbable calcium salt bone void filler device.
888.3045
COMMON NAMEFiller, bone void, calcium compound
PROPRIETARY NAMESolum IV Bone Void Filler

IDENTIFICATION OF PREDICATE DEVICES:

Solum IV was determined to be substantially equivalent to the previously cleared nanOss BVF-E. K081558. Pioneer Surgical Technology. Cleared August 25. 2008. Solum IV is similar to nanOss BVF-E in characteristics which includes indication, ceramic materials, gelatin carrier, structure and presentation.

DEVICE DESCRIPTION:

Solum IV ® is a resorbable porous calcium phosphate bone void filler mixed with a porcine gelatin based carrier. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone.It is provided sterile in various configurations within a double sealed package containing a mixing spatula.

INDICATIONS:

Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow

1

aspirate. These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

TECHNOLOGICAL CHARACTERISTICS:

Solum IV ® is composed of porous hydroaxyapatite granules and a Type A porcine gelatin based carrier. The granules consist of macroporous ceramic granules composed of greater than 95% hydroxyapatite (HAp). The calcium phosphate granuals are presented as ground particles. The macroporous sturcture of Solum IV provides a resorbable osteoconductive scaffold.

The gelatin based carrier is presented as ground freeze-dried particles. The product forms a cohesive and adhesive dough with a putty-like consistency upon hydration which allows the shape of the implant to conform to the defect maximizing direct contact with viable host bone.

A summay of the technological characteristics comparing Solum IV to the predicate nanOss BVF-E (K081558) is listed in the table below.

| Specification | Solum IV | Predicate
nanOss |
|---------------------------------------------|---------------------------|---------------------------|
| Device Material | Type A Gelatin
and HAp | Type A Gelatin
and HAp |
| Particle Size | .5mm-2.5mm | .5mm-2.5mm |
| Ca/P Ratio | 1.66 | 1.66 |
| Porosity
(As determined
by % Density) | 80% | 71% |
| Crystalline
Structure | >95% | >95% |

TESTING:

Solum IV and/or its components have undergone non-clinical testing including chemical. physical, animal, component biocompatibility, and handling characteristics. A critically sized defect implantation animal study demonstrated that Solum IV performed as well as the predicate device. Testing has provided a reasonable assurance of safety and effectiveness for its intended use with respect to the predicate device and supports a determination of substantial equivalence to the predicate device.

CONCLUSIONS:

The comparisons and testing conducted on Solum IV demonstrate that Solum IV and the predicated device nanOss BVF-E (K081558) have similar technological characteristics, intended use, and in vivo performance in a critically sized defect animal study, and therefore are substantially equivalent.

2

Public Health Service

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three overlapping shapes representing arms or wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 21, 2014

SpineSmith Partners, LLP Mr. Clifton (Chris) Naivar Director, Quality and Regulatory Affairs 93 Red River Street Austin, Texas 78701

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K132470

Trade/Device Name: Solum IV Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 14, 2014 Received: April 15, 2014

Dear Mr. Naivar:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

3

Page 2 – Mr. Clifton (Chris) Naivar

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K132470 - page 1 of 1

INDICATIONS FOR USE

510(k) Number (if known): K132470

Device Name: Solum IV Bone Void Filler

Indications for Use:

Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow aspirate. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132470