ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

K061880 · Isotis NV · MQV · Aug 15, 2007 · Orthopedic

Device Facts

• Record ID: K061880
• Device Name: ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
• Applicant: Isotis NV
• Product Code: MQV · Orthopedic
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Device Story

Accell Family of products (Accell DBM 100, Accell TBM, A2i, Accell Connexus) are osteoconductive human allogenic demineralized bone matrix (DBM) materials used in orthopaedic surgery. Products consist of ground cortical allograft bone combined with up to 70% poloxamer reverse phase medium (RPM) carrier. RPM acts as a containing agent to improve handling characteristics. Used by surgeons to fill skeletal voids or gaps not intrinsic to bony stability; applied as bone graft extenders or void fillers. Device provides a scaffold for bone remodeling. Clinical benefit derived from filling defects caused by trauma or surgery to support healing. Each lot tested for osteoinductive potential via in vitro cell culture assay correlated to athymic rat models.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (pH, physical characteristics, appearance), viral inactivation validation, and animal studies. Animal studies included resorption analysis in rats and rabbit tibial/spinal fusion models. Osteoinductive potential verified via in vitro cell culture assay validated against athymic rat models. Viral inactivation studies confirmed efficacy across a panel of representative viruses.

Technological Characteristics

Materials: Human allogenic demineralized bone matrix (DBM) and poloxamer reverse phase medium (RPM) carrier (up to 70%). Principle: Osteoconductive scaffold for bone void filling. Form factor: Paste/putty/gel-like handling. Sterilization: Terminal sterilization processing. Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring bone graft extension in the spine, extremities, and pelvis, or bone void filling in the extremities and pelvis, due to surgically created defects or traumatic injury. Not for use in areas intrinsic to the stability of the bony structure.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• DynaGraft II Paste and Putty (K040419)
• AlloMatrix DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980)
• InterGro DBM with inert carrier Lecithin (K031399)
• Osteofil Paste DBM with inert carrier Porcine Collagen (K043420)

Reference Devices

• Connexus (K050690)
• Connexus (K052098)

Submission Summary (Full Text)

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KO61880

# AUG 1 5 2007

# 510(K) SUMMARY

### IsoTis Accell DBM Family of Products

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED

> IsoTis OrthoBiologics, Inc. 2 Goodvear Irvine CA 92618 U.S.A.

- [phone] PHONE:
- Contact Person: Karon Morell
- Date Prepared: August 10, 2007

NAME OF DEVICE:

Accell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus)

#### Common or Usual Name

Bone Void Filler

#### CLASSIFICATION NAME

21 C.F.R. § 888.3045 Resorbable calcium salt bone void filler device

#### PREDICATE DEVICES

DynaGraft II Paste and Putty (K040419) AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with inert carrier Porcine Collagen (K043420)

#### INTENDED USE/INDICATIONS

The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

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#### DEVICE DESCRIPTION

Accell DBM family of products are used for orthopaedic bone grafting procedures. They are osteoconductive human allogenic demineralized bone filling materials for use as fillers for gaps or voids that are not intrinsic to the stability of the bony structure.

Accell DBM family of products are products that are manufactured using human donor demineralized bone and may contain up to 70% poloxamer reverse phase medium carrier (RPM). The demineralized bone is derived from human ground, cortical allograft bone. Poloxamer RPM is an inactive product ingredient that is utilized as a containing agent for the demineralized bone and provides appropriate product handling characteristics for the products.

The products of the Accell DBM family are comprised of the same DBM and RPM components as found in DynaGraft II Gel, FDA cleared under 510(k) number K040419 and Connexus cleared under 510(k)'s K050690 and K052098. In addition, the Accell DBM family of products may contain up to a maximum of 70% of RPM carrier. This is the concentration of RPM already cleared in DynaGraft II gel.

#### SUMMARY OF PERFORMANCE TESTING

The poloxamer RPM granules used to prepare the carrier in two of the Accell DBM family of products are characterized to confirm the chemical composition. The carrier is analyzed for pH, physical characteristics and appearance. A resorption study has been performed to examine the rate and extent of carrier elimination in male adult rats.

Resorption of the DBM was demonstrated during rabbit animal studies. After 12 weeks, very little of the DBM could be detected and most had been remodeled.

Viral inactivation studies have been performed for the demineralization process in combination with terminal sterilization processing.

Several animal studies were performed on both Connexus and DynaGraft II Gel and were submitted as part of their original 510(k) submissions (K050690 and K040419). Additional animal studies have been performed and previously submitted in the 510(k) supplements, for the Accell DBM family of products. These studies included rabbit tibial critical size defects and rabbit spinal fusion studies.

These studies confirmed that the Accell products raised no safety or performance issues and are substantially equivalent to the predicate device, DynaGraft II Gel Demineralized Bone Matrix.

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### Osteoinducitive Potential

Each lot of DBM used to manufacture the Accell DBM family of products is tested for osteoinductive potential using an in vitro cell culture test. The in vitro cell culture assay has been validated to correlate to an athymic rat osteoinductive potential assay. It is unknown how osteoinductivity potential, measured via the in vitro cell culture or athymic rat assays, will correlate with human clinical performance.

#### VIRAL INACTIVATION VALIDATION

The methods for processing of the DBM contained in the Accell Family of products were evaluated for their viral inactivation potential. A selected panel of viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable inactivation potential of the processing methods for a wide range of potential viruses.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 15 2007

IsoTis OrthoBiologics, Inc. c/o Ms. Karen Morell Director Ouality Assurance and Regulatory Affairs 2 Goodyear Irvine, CA 92618

Re: K061880

Trade Name: Accell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MOV Dated: May 28, 2007 Received: May 30, 2007

Dear Ms. Morell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if

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#### Page 2 - Ms. Karen Morell

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours.

Barbara Buell

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): K061880

Accell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Device Name: Connexus)

Indications for Use:

The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Prescription Use ✔ (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sarbare Buell

Division of General, Restorative and Neurological Devices

510(k) Number K0 6 1880

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