K Number
K152620
Device Name
Spine Wave Gen II Expandable Interbody System
Manufacturer
Date Cleared
2016-01-15

(123 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Device Description
The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.
More Information

No
The summary describes a mechanical expandable interbody fusion system and its materials, with no mention of AI or ML in the intended use, device description, or performance studies.

Yes
The device is a medical implant designed to treat degenerative disc disease by facilitating intervertebral body fusion, which is a therapeutic intervention.

No

This device is an implantable intervertebral body fusion system, not a diagnostic device. Its purpose is to facilitate fusion, not to diagnose medical conditions.

No

The device description clearly states it is composed of physical components (wafers, implants, delivery device) made of titanium alloy, PEEK, and commercially pure titanium. It is an expandable interbody system for spinal fusion, which is a hardware implant.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The provided text clearly describes a surgical implant (an expandable interbody system) used in the lumbar spine for fusion procedures. It is a physical device implanted into the body, not used to test samples outside the body.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic tests performed on specimens.

Therefore, based on the provided information, the Spine Wave Gen II Expandable Interbody System is a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Product codes

MAX

Device Description

The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine at one or two contiguous levels from L2-S1; L2-L5

Indicated Patient Age Range

skeletally mature patients

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 tests have been performed for characterization of the commercially pure titanium coating to demonstrate substantial equivalence of the system to its predicate:

  • Coating Microstructure (ASTM F1854)
  • Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (ASTM F1044)
  • Shear Fatigue Testing (ASTM F1160)
  • Tensile Testing (ASTM F1147)
  • Abrasion Testing (ASTM F1978)

The following mechanical tests were performed to demonstrate the substantial equivalence of the system to its predicates:

  • Static and dynamic axial compression (per ASTM F2077)
  • Static and dynamic compression shear (per ASTM F2077)
  • Subsidence (per ASTM F2267)
  • Wear Debris Analysis (per ASTM F1877)

Key Metrics

Not Found

Predicate Device(s)

K131071, K132719, K123461, K123231, K122097, K113285, K103814, K140007, K141791, K072253

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

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

January 15, 2016

Spine Wave, Incorporated Ms. Gail Yaeker-Daunis Senior Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K152620

Trade/Device Name: Spine Wave Gen II Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 16, 2015 Received: December 17, 2015

Dear Ms. Yaeker-Daunis:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K152620

Spine Wave Gen II Expandable Interbody System

Indications for Use (Describe)

The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Spine Wave Gen II Expandable Interbody System

1. Submitter Information

Submitter:Spine Wave, Inc.
Address:Three Enterprise Drive
Suite 210
Shelton, CT 06484
Telephone:203-712-1894
Telefax:203-944-9493
Contact:Gail Yaeker-Daunis
Date Prepared:January 14, 2016

2. Device Information

Trade Name:Spine Wave Gen II Expandable Interbody System
Common Name:Intervertebral Body Fusion Device
Classification:Class II (special controls) per 21 CFR 888.3080
Classification Name:Intervertebral Fusion Device with Bone Graft, Lumba
Product Code:MAX

3. Purpose of Submission

The purpose of this submission is to gain clearance for a new intervertebral body fusion device.

4. Predicate Device Information

The Spine Wave Gen II Expandable Interbody System described in this submission is substantially equivalent to the following predicates:

4

DeviceManufacturer510(k) No.
Primary PredicateStaXx® IBL SystemSpine Wave, Inc.K131071
Additional PredicateStaXx® IBL SystemSpine Wave, Inc.K132719
Additional PredicateStaXx® IBSpine Wave, IncK123461
Additional PredicateCaliber®/ Caliber L®
SpacerGlobus Medical Inc.K123231
Additional PredicatePatriot® SpacerGlobus Medical Inc.K122097
Additional PredicateLDR Spine USA
Avenue® L Interbody
Fusion SystemLDR Spine USAK113285
Additional PredicatePezo TM PEEK Cage
FamilyUlrich GmbH & Co.
KGK103814
Additional PredicateAbacus® Spacer
SystemSpine Wave, Inc.K140007
Additional PredicateBiomet Fusion SystemBiomet SpineK141791
Additional PredicateSynfix-LR SPACERSynthes Spine Co. LPK072253

5. Device Description

The Gen II Expandable Interbody System is composed of wafers that are stacked into an expandable implant to adjust the height of the implants are manufactured of titanium alloy (Ti-6AI-4V, ASTM F136), PEEK-OPTIMA with 6% BaSO4, and commercially pure titanium (ASTM F1580). The Spine Wave Gen II Expandable Interbody System Implants are provided in various configurations to address the anatomical needs of a variety of patients and to accommodate various surgical approaches to the lumbar spine. The implants are to be used with autogenous bone graft material and supplemental fixation. The System also includes a delivery device that is used to both place and expand the implant. The implants are provided sterile.

6. Indications for Use

The Spine Wave Gen II Expandable Interbody System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1 when implanted using a posterior surgical approach and levels L2-L5 when implanted using a lateral surgical approach. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

7. Comparison of Technological Characteristics

5

The substantial equivalence of the Spine Wave Gen II Expandable Interbody System to predicates is shown by similarity in intended use, indications for use, materials and performance.

8. Non-Clinical Performance Data

The following tests have been performed for characterization of the commercially pure titanium coating to demonstrate substantial equivalence of the system to its predicate:

  • . Coating Microstructure (ASTM F1854)
  • . Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (ASTM F1044)
  • Shear Fatigue Testing (ASTM F1160) .
  • . Tensile Testing (ASTM F1147)
  • Abrasion Testing (ASTM F1978) ●

The following mechanical tests were performed to demonstrate the substantial equivalence of the system to its predicates:

  • Static and dynamic axial compression (per ASTM F2077) ●
  • Static and dynamic compression shear (per ASTM F2077)
  • Subsidence (per ASTM F2267) ●
  • Wear Debris Analysis (per ASTM F1877)

9. Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Spine Wave Gen II Expandable Interbody System has been shown to be substantially equivalent to the predicate devices identified in this submission.