(211 days)
Not Found
No
The document describes a mechanical interbody fusion device and its applicator. There is no mention of AI, ML, or any software-driven analytical capabilities. The "radios" mentioned are used for diagnosis, not as input for the device's function.
No.
A therapeutic device actively treats or cures a condition. This device, the T-PAL Spacer, is an implant used in spinal fusion to provide structural stability and is used with supplemental fixation and bone graft, but it does not inherently treat the degenerative disc disease itself; rather, it aids in the fusion process to stabilize the spine and alleviate symptoms.
No
The device is an interbody fusion device (T-PAL Spacer) used for structural stability after discectomy, and the T-PAL Applicator is used to insert it. Its function is therapeutic/surgical, not diagnostic. While the "Indications for Use" mentions "radios" as a way to confirm disc degeneration, the device itself does not perform the diagnostic imaging or analysis.
No
The device description clearly states it is an interbody fusion device (a physical implant) and an applicator (a physical tool), not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The T-PAL Spacer System is an implantable device used in spinal fusion surgery. It is inserted into the disc space to provide structural stability.
- Intended Use: The intended use is to treat degenerative disc disease by providing interbody fusion and structural support, not to analyze biological samples.
- No Mention of Biological Samples: The description and intended use do not involve the analysis of any biological specimens.
The device is a surgical implant used directly within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had six months of nonoperative treatment.
The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The T-PAL Spacer System is an interbody fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following intervertebral discectomy. The T-PAL Applicator is used to insert the T-PAL Spacer into the disc space. The T-PAL Applicator is composed of an inner shaft and handle (outer shaft). The scope of this submission is to develop an additional T-PAL Applicator option for surgeons to facilitate insertion of the T-PAL Spacer and final positioning in the interbody disc space.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Spine, L2 to S1
Indicated Patient Age Range
Skeletally mature
Intended User / Care Setting
Surgeons
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)
The new T-PAL Advanced Applicator is a minor modification to the currently cleared T-PAL Applicator, the modification and does not change the fundamental scientific technology of the device. Based on a review of the performance data, the subject T-PAL Advanced Applicator does not represent a worst case from a mechanical testing standpoint. The mechanical testing simulated the insertion of the implant into an intervertebral body using the subject T-PAL Advanced Applicator. The performance acceptance criteria was met. The conclusion of the testing criteria demonstrates the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters 'FDA' in white, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue. To the left of the FDA logo is the Department of Health & Human Services seal, which includes an emblem with a caduceus-like symbol and the text 'DEPARTMENT OF HEALTH & HUMAN SERVICES-USA' arranged around it.
December 6, 2018
DePuy Synthes Spine Ms. Rozanne Shirley Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K181231
Trade/Device Name: DePuy Synthes T-PAL Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 5, 2018 Received: November 6, 2018
Dear Ms. Shirley:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 0613012020 See PRA Statement below.
510(k) Number K181231
Device Name DePuy Synthes T-PAL Spacer System
Indications for Use (Describe)
The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had six months of nonoperative treatment.
The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.
Type of Use (Select one or both, as applicable) ×PrescriptionUse(Part21CFR801SubpartD) □ Over-The-Counter Use (21 CFR 801 Subpart C ) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301
3
510(k) Summary
A. Submitter Information
| 510(k) Sponsor: | Synthes USA, LLC
1101 Synthes Avenue
Monument, CO 80132 USA |
|-------------------------|-------------------------------------------------------------------|
| Submitter: | DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767 |
| Contact Person: | Rozanne Shirley
325 Paramount Drive
Raynham, MA 02767 |
| Telephone number: | (508) 977-6304 |
| Email: | rshirle1@its.jnj.com |
| B. Date Prepared | December 6, 2018 |
| C. Device Name | |
| Trade/Proprietary Name: | DePuy Synthes T-PAL Spacer System |
| Common/Usual Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification Name: | Intervertebral Fusion, per 21 CFR 888.3080 |
| Product Code: | MAX |
| Predicate Device Name | |
| Primary Predicate Trade Name: | T-PAL Spacer System (K100089) |
|---|---|
| Additional Predicate Device: | DePuy Synthes T-PAL Ti Spacer System (K151276) |
D. Device Description
The T-PAL Spacer System is an interbody fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following intervertebral discectomy. The T-PAL Applicator is used to insert the T-PAL Spacer into the disc space. The T-PAL Applicator is composed of an inner shaft and handle (outer shaft). The scope of this submission is to develop an additional T-PAL Applicator option for surgeons to
4
facilitate insertion of the T-PAL Spacer and final positioning in the interbody disc space.
E. Indications for Use
The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.
- F. Summary of Similarities and Differences in Technological Characteristics, and Intended Use The intended use, method of sterilization, fundamental scientific technology, and function of the T-PAL Advanced Applicator is identical to the predicate devices, K100089 and K151276. The T-PAL Advanced Applicator has similar but not identical design and performance as the current T-PAL Applicator, due to minor modifications to the handle and inner shaft. The main difference between the predicate device and the subject device includes a modification to the T-PAL Advanced Applicator inner shaft to now have a biased claw design with an elongated finger and a higher pivoting angle to allow for greater flexibility in the angle of approach and to facilitate implant release. The minor modification to the width of the distal end of the T-PAL Advanced Applicator Handle is to accommodate for the new inner shaft, and current implants and trial spacers. In addition, there is a minor design modification to the base material of the distal end of the handle. The predicate device will not be replaced by the subject device in the market.
G. Materials
The T-PAL Applicator and T-PAL Advanced Applicator are manufactured from a medical grade stainless steel. The material used to manufacture the T-PAL Advanced Applicator Inner Shaft is identical to the predicate. T-PAL Applicator Inner Shaft. The T-PAL Applicator and T-PAL Advanced Applicator Handles are composed of silicone rubber and stainless steel. The stainlesssteel material of the distal end of the T-PAL Advanced Applicator (outer shaft) is being modified from a 17-4 PH Stainless Steel to a Custom 465cw Stainless Steel. Other than this change, the materials and manufacturing of the subject device are identical to those of the predicate device.
H. Performance Data
The new T-PAL Advanced Applicator is a minor modification to the currently cleared T-PAL Applicator, the modification and does not change the fundamental scientific technology of the device. Based on a review of the performance data, the subject T-PAL Advanced Applicator does not represent a worst case from a mechanical testing standpoint. The mechanical testing simulated the insertion of the implant into an intervertebral body using the subject T-PAL Advanced Applicator. The performance acceptance criteria was met. The conclusion of the testing criteria demonstrates the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
5
I. Conclusion
The subject device, T-PAL Advanced Applicator, is substantially equivalent to the predicate devices because the intended use remains unchanged due to the changes to the device and technological characteristics of the subject device are similar to the predicate. The insertion testing further demonstrates that the modifications to the design do not introduce any new questions of safety and effectiveness.