K Number
K100210
Device Name
TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T
Date Cleared
2010-08-26

(213 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.
Device Description
The TranS1® Lateral Interbody Fusion Device is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also includes curved access instruments and disc preparation instruments. The TranS1® Lateral Interbody Fuson Device provides a lateral approach to the spine from a posterior angle while the patient is in a prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and the patient is already in the prone position which eliminates the need to flip the patient for supplemental posterior fixation. It is designed for use to provide structural stability in skeletally mature individuals.
More Information

No Reference Device(s)

No
The 510(k) summary describes a mechanical interbody fusion device and surgical instruments, with no mention of AI or ML in the intended use, device description, or performance studies.

No
The device is an implant for spinal fusion and provides structural stability, which is not considered a therapeutic function by itself.

No

The device is an interbody fusion implant used in spinal fusion procedures to provide structural stability, not to diagnose a condition.

No

The device description explicitly states it is a radiolucent PEEK interbody fusion implant and includes physical instruments, indicating it is a hardware device, not software-only.

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

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description and Intended Use: The description clearly states that the TranS1 Lateral Interbody Fusion Device is an implant used in spinal fusion procedures. It is a physical device inserted into the body to provide structural stability.
  • Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or providing diagnostic information based on such analysis.

Therefore, the TranS1 Lateral Interbody Fusion Device falls under the category of a surgical implant or medical device used for treatment, not an in vitro diagnostic.

N/A

Intended Use / Indications for Use

The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.

Product codes

MAX

Device Description

The TranS1® Lateral Interbody Fusion Device is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also includes curved access instruments and disc preparation instruments. The TranS1® Lateral Interbody Fuson Device provides a lateral approach to the spine from a posterior angle while the patient is in a prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and the patient is already in the prone position which eliminates the need to flip the patient for supplemental posterior fixation. It is designed for use to provide structural stability in skeletally mature individuals.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spinal fusion procedures, L2-S1

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Mechanical testing for the TranS1 Lateral Interbody Fusion Device was performed per ASTM standards and included Static Axial Compression Strength (ASTM 2077-03), Static Subsidence (ASTM 2267-04), Static Push-out (ASTM Draft Standard F-04.25.02.02 and ASTM 2077-03) and Dynamic Axial Compression (Fatigue) (ASTM 2077-03). All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. No new safety or effectiveness questions were raised as a result of the testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K073177, K090425

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.

0

Trans

Premarket Notification [510(K)] Summary (per 21 CFR 807 92)

(pc) 21.01.1901.02

August 16, 2010

AUG 26 2010

Submitter: Contact Person: TranS1, Inc. Cheryl L Wagoner 411 Landmark Drive Director of Regulatory Wilmington, NC 28412 910-332-1703 (phone). 910-233-7105 (fax) Proprietary Name: TranS1® Lateral Interbody Fusion Classification: 888.3080: Intervertebral Fusion Device (MAX) Predicate Device: . Pioneer Surgical Technology: Pioneer Intervertebral Body Fusion System (K073177) . Alphatec Spinte, Inc: Guided Lateral Interbody Fusion (GLIF) System

Indications and Intended use:

The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Lateral Interbody Fusion Device is designed to be used with autogenous graff.

Device Description

The TranS1® Lateral Interbody Fusion Device is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also includes curved access instruments and disc preparation instruments. The TranS1® Lateral Interbody Fuson Device provides a lateral approach to the spine from a posterior angle while the patient is in a prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and the patient is already in the prone position which eliminates the need to flip the patient for supplemental posterior fixation. It is designed for use to provide structural stability in skeletally mature individuals.

Technological Characteristics and Substantial Equivalence

Documentation was provided to demonstrate that the TranS1® Lateral Interbody Fusion Device is substantially equivalent to the predicate Pioneer Intervetebral Body Fusion System (K073177) and Alphatec GLIF (K090425). The TranS1 device is substantially equivalent to the predicate devices in intended use, level of attachment, materials, labeling, and technological characteristics. These devices have the same intended use and indications and rely on the same fundamental scientific technology; therefore the Subject device is substantially equivalent to the Predicate devices

Summary of Testing

Mechanical testing for the TranS1 Lateral Interbody Fusion Device was performed per ASTM standards and included Static Axial Compression Strength (ASTM 2077-03), Static Subsidence (ASTM 2267-04), Static Push-out (ASTM Draft Standard F-04.25.02.02 and ASTM 2077-03) and Dynamic Axial Compression (Fatigue) (ASTM 2077-03). All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. No new safety or effectiveness questions were raised as a result of the testing.

Pg 1 of 1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or abstract human figure, with three curved lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Public Health Service

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

TranS1, Inc. % Ms. Cheryl L. Wagoner Director of Regulatory 411 Landmark Drive Wilmington, North Carolina 28412

AUG 2 6 2010

Re: K100210

Trade/Device Name: TranS1® Lateral Intervertebral Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 16, 2010 Received: August 18, 2010

Dear Ms. Wagoner:

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

2

Page 2 - Ms. Cheryl L. Wagoner

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 vours.

De. Dav. Omehid

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

Enclosure

3

Statement of Indications for Use

Page 1 of 1

510(k) Number: K100210

AUG 26 2010

Device Name: TranS1® Lateral Interbody Fusion Device

Indications for Use:

The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K100210 510(k) Number_