(75 days)
Not Found
No
The 510(k) summary describes a passive intervertebral body fusion device and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is described as an intervertebral body fusion device used to treat degenerative disc disease and facilitate bone fusion, which are therapeutic actions.
No
The device is an intervertebral body fusion device used for treatment, not for diagnosing medical conditions. The "Indications for Use" section specifies its purpose for intervertebral body fusion procedures for degenerative disc disease.
No
The device description clearly states it is a "hollow device with texture on two opposing convex sides" and is offered in various physical dimensions, indicating it is a physical implant, not software.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (an intervertebral body fusion device) used to treat degenerative disc disease in the lumbar spine. It is physically implanted into the patient's body.
The device's function is to provide structural support and facilitate bone fusion, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The IMSE P-TLIF 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). IMSEP-TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
IMSEP-TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
Institute of Musculoskeletal Science and Education, P-TLIF is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces.
IMSE, P-TLIF is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Institute of Musculoskeletal Science and Education designed the IMSE, P-TLIF to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
lumbar spine at one or two contiguous levels from 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)
Nonclinical Test Summary: The following tests were performed to demonstrate that the IMSEP-TLIF is substantially equivalent to other predicate devices. Static and Dynamic Compression Test per ASTM F2077, Static and Dynamic Compression Shear ASTM F2077, Subsidence Test per ASTM F2267, Wear Debris ASTM F2077 and ASTM F1877, Static Expulsion Test. The results of these studies showed that the IMSEP-TLIF met the acceptance criteria.
Clinical Test Summary: No clinical tests were performed.
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.
Camber Cage (K121254), Corelink Foundation Cage (K 073440), Stryker AVS PL (K093704) & K2M Aleutian (K113138)
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
§ 888.3080 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
Page 1 of 4
MAY 1 3 2013
ಕ
Image /page/0/Picture/2 description: The image is a logo that is divided into four squares. The top left square contains the letter 'i', the top right square contains the letter 'm', the bottom left square contains the letter 's', and the bottom right square contains the letter 'e'. Below the four squares is the text 'The Institute of Musculoskeletal Science & Education'.
510(k) Summary
as required by section 807.92(c).
P-TLIF
K130506
Institute of Musculoskeletal Science & Education
90 S. Newtown Street Rd., Suite #10
Newtown Square, PA 19073
John Moran
CEO
Phone: 484-420-4219
Fax: 484 318-8031
Email: mberwyn@aol.com
Submitted 4/4/13
1
MAY 1 3 2013
Page 2 of 4
.
| Submitter: | Institute of Musculoskeletal Science & Education |
|---|---|
| 90 S. Newtown Street Rd., Suite #10 | |
| Newtown Square, PA 19073 | |
| Contact Person | John Moran |
| CEO | |
| Phone: (484) 420-4219 | |
| Email: mberwyn@aol.com |
| Trade Name | IMSE P-TLIF |
|---|---|
| Common Name | P-TLIF |
| Device Class | Class II |
| Classification Name | |
| and Number | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 21 CFR 888.3080 | |
| Classification Panel: | Orthopedic |
| Product Code | MAX |
| Reason for 510k | New Device |
| Predicate Devices | Camber Cage (K121254), Corelink Foundation Cage (K 073440), |
| Stryker AVS PL (K093704) & K2M Aleutian (K113138) | |
| Device Description | Institute of Musculoskeletal Science and Education, P-TLIF is a device |
| for interbody fusion of the anterior column of the spine. These cages | |
| are hollow so that bone can grow through the device, fusing the | |
| adjacent bony surfaces. | |
| IMSE, P-TLIF is a hollow device with texture on two opposing convex | |
| sides, and is offered in various lengths, widths, heights and shapes. | |
| Institute of Musculoskeletal Science and Education designed the | |
| IMSE, P-TLIF to be placed through a transforaminal or posterior | |
| approach and to address vertebrae in the lumbosacral region of the | |
| spine. |
.
2
2
K130506 Page 3 of 4
| The IMSE P-TLIF is indicated for intervertebral body fusion procedures in | |
|---|---|
| Intended Use | skeletally mature patients with degenerative disc disease (DDD) of the |
| lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as | |
| discogenic pain with degeneration of the disc confirmed by history and | |
| radiographic studies. These DDD patients may also have up to Grade I | |
| spondylolisthesis or retrolisthesis at the involved level(s). IMSEP-TLIF is to | |
| be used with autologous bone graft and implanted via an open | |
| transforaminal or posterior approach. | |
| IMSEP-TLIF implants are to be used with supplemental fixation. Patients | |
| should have at least six (6) months of non-operative treatment prior to | |
| treatment with an intervertebral cage. | |
| Materials: | The implant is manufactured from ASTM2026 Solvay Zeniva
ZA-500 implant grade Polyetheretherketone (PEEK) |
| ------------ | ------------------------------------------------------------------------------------------------------------- |
|---|
| Statement of
Technological
Comparison | IMSE, P-TLIF and its predicate devices have the same indications for use,
similar design, and test results. Both devices are manufactured using
materials with a long history of use in orthopaedic implants. |
| --------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
.
3
. K130506 Page 4 of 4
| Nonclinical Test | The following tests were performed to demonstrate that the IMSEP-TLIF is substantially | |
|---|---|---|
| Summary | equivalent to other predicate devices. | |
| Static and Dynamic Compression Test per ASTM F2077 | ||
| Static and Dynamic Compression Shear ASTM F2077 | ||
| Subsidence Test per ASTM F2267 | ||
| Wear Debris ASTM F2077 and ASTM F1877 | ||
| Static Expulsion Test | ||
| The results of these studies showed that the IMSEP-TLIF met the acceptance criteria. | ||
| Clinical Test | ||
| Summary | No clinical tests were performed. |
| Sterilization Information | |
|---|---|
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing of |
| the process was conducted (using the half-cycle method) to a Sterility Assurance Level | |
| (SAL) of 10-6 per ISO 17665. | |
| Instruments and | The instrument and case will be shipped non-sterile and will be autoclaveable, |
| Case | validation testing of the process was conducted (using the half-cycle method) to a |
| Sterility Assurance Level (SAL) of 10-6 per ISO 17665. |
| Conclusion | The IMSE, P-TLIF is substantially equivalent to its predicate devices. This conclusion is
based upon the fact the Lumbar Cage and its predicate devices have the same
indications for use, have a similar design and technical characteristics, similar test
results, and any differences do not raise question of safety and effectiveness. |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
:
·
:
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle, possibly representing water or movement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Institute of Musculoskeletal Science & Education % Mr. John Moran CEO 90 South Newtown Street Road, Suite #10 Newtown Square, Pennsylvania 19073
Re: K130506
Trade/Device Name: IMSE P-TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Codes: MAX Dated: April 5, 2013 Received: April 5, 2013
Dear Mr. Moran:
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
Letter dated: May 13, 2013
5
Page 2 - Mr. John Moran
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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark NMelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: IMSE P-TLIF Device Name:
Indications:
The Institute of Musculoskeletal Science & Education P-TUF 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. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). institute of Musculoskeletal Science & Education P-TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Institute of Musculoskeletal Science & Education P-TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
AND/OR Over-the-counter Prescription Use X (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices