(20 days)
No
The summary describes a physical spinal implant made of titanium, manufactured using additive manufacturing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
No.
The device is an intervertebral body fusion cage, which is an implant used to facilitate spinal fusion, not a therapeutic device designed to treat or cure a disease through active therapy.
No
The device is an intervertebral cage used to facilitate spinal fusion in patients with degenerative disc disease, not to diagnose the condition.
No
The device description explicitly states the device is made from medical grade titanium alloy and is a physical implant (intervertebral body spacer).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health.
- This device is an implant. It is a physical object inserted into the body to treat a condition (degenerative disc disease).
The description clearly states that the TRYPTIK®Ti cages are "spinal implants" used to "facilitate intervertebral body fusion in the cervical spine." This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages are used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages are to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
ODP
Device Description
Spineart Tryptik® Ti spinal implants consist in a range of intervertebral body spacers with various shapes and designs so as to be implanted via an anterior cervical approach and to adapt different patient's conditions. The Tryptik® Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The subject implants Tryptik® Ti will extend the previously cleared Tryptik® Ti range of implants (K200312) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM), and join the previously cleared Tryptik® Ti range of implants (K200312) which addresses the same indications and utilize the same instrumentation designed purposely. The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2 to T1 disc
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)
The following non-clinical tests were conducted on predicate devices: Static axial compression, Static shear compression, Static torsion according to ASTM F2077 and subsidence testing according to ASTM F2267. A engineering rationale has been provided to support substantial equivalence. No additional testing has been performed for the Spineart Tryptik® Ti line extension spinal implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Primary predicate: Tryptik® Ti (K200312), Additional predicates: Tyber Medical PT Interbody Spacer (K182284)
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
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March 22, 2023
Spineart SA Franck Pennesi Chief Technical Officer 3 Chemin du Pré -Fleuri Plan-les-Ouates, Geneve 1228 Switzerland
Re: K230583
Trade/Device Name: Tryptik® Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 27, 2023 Received: March 2, 2023
Dear Franck Pennesi:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230583
Device Name TRYPTIK®Ti
Indications for Use (Describe)
TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages are used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages are to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Special 510k Tryptik® Ti
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510(k) SUMMARY
| 510k | SPECIAL |
|---|---|
| Basis for submission | Extension of the range of Tryptik® Ti devices |
| Submitted by | SPINEART |
| 3 Chemin du Pré-Fleuri | |
| 1228 PLAN LES OUATES | |
| GENEVA SWITZERLAND | |
| Contacts | Franck PENNESI Chief Technical Officer |
| Phone : +41 22 570 1200 Fax : +41 22 594 8306 | |
| Mail : fpennesi@spineart.com | |
| Regulatory contact : Estelle LEFEUVRE elefeuvre@spineart.com | |
| Date Prepared | February 21st, 2023 |
| Common Name | Intervertebral body fusion device |
| Trade Name | Tryptik® Ti |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Cervical |
| Class | II |
| Product Code | ODP |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate: Tryptik® Ti (K200312) manufactured by Spineart |
| Additional predicates: Tyber Medical PT Interbody Spacer (K182284) manufactured by Tyber Medical LLC | |
| Indications for use | TRYPTIK®Ti cages are indicated for use in skeletally mature patients |
| with degenerative disc disease (DDD) of the cervical spine with | |
| accompanying radicular symptoms at one level or two contiguous disc | |
| levels from C2 to T1 disc. DDD is defined as discogenic pain with | |
| degeneration of the disc confirmed by patient history and radiographic | |
| studies. TRYPTIK®Ti cages are used to facilitate intervertebral body | |
| fusion in the cervical spine using autogenous and/or allogeneic bone | |
| graft comprised of cancellous and/or corticocancellous bone graft. | |
| TRYPTIK®Ti cages are to be used with supplemental fixation that has | |
| been cleared for use in the cervical spine. Patients should have at least | |
| six (6) weeks of non-operative treatment prior to treatment with an | |
| intervertebral cage. |
4
| Description of the device | Spineart Tryptik® Ti spinal implants consist in a range of intervertebral
body spacers with various shapes and designs so as to be implanted via
an anterior cervical approach and to adapt different patient's conditions.
The Tryptik® Ti spacers are all made from medical grade titanium alloy
conforming to ASTM F136 standard and are produced by additive
manufacturing (SLM) according to ASTM F3001. Subsequently the
spacer is machined (thread tapping) and polished.
The subject implants Tryptik® Ti will extend the previously cleared
Tryptik® Ti range of implants (K200312) which presents similar design
features and the same manufacturing technology, i.e. additive
manufacturing (SLM), and join the previously cleared Tryptik® Ti range
of implants (K200312) which addresses the same indications and utilize
the same instrumentation designed purposely.
The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization)
and supplied with dedicated surgical instruments (reusable – provided
non-sterile). |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics
compared to the
predicate devices | The Tryptik® Ti spinal implants are manufactured using the same
manufacturing technology, i.e. additive manufacturing (SLM) as
predicate device Tryptik® Ti. The characterization of the chemical,
physical and mechanical properties of the material was performed in
accordance with ASTM F3001 and ASTM E8/E8M.
The Tryptik® Ti spinal implants present a similar design feature and
range of devices as the previously cleared Tryptik® Ti spinal implants.
Both Tryptik® Ti and Tryptik® Ti extension line are designed for an
anterior approach.
The following non-clinical tests were conducted on predicate devices:
Static axial compression, Static shear compression, Static torsion
according to ASTM F2077 and subsidence testing according to ASTM
F2267. A engineering rationale has been provided to support substantial
equivalence. |
| Discussion of Testing | No additional testing has been performed for the Spineart Tryptik® Ti line
extension spinal implants. |
| Conclusion | Based on the design features, technological characteristics, feature
comparisons, and indications for use, Tryptik® Ti line extension has
demonstrated substantial equivalence to the identified predicate devices. |