(60 days)
No
The summary describes a physical interbody fusion device and its mechanical properties, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is described as an anterior cervical interbody fusion device for patients with degenerative disc disease, used to facilitate intervertebral body fusion in the cervical spine to treat pain and degeneration. This aligns with the definition of a therapeutic device which is intended to treat or alleviate a disease or condition.
No
Explanation: The device is an intervertebral body fusion device (TRYPTIK®Ti cages) used to facilitate fusion in the cervical spine. While its use is for patients with "degeneration of the disc confirmed by patient history and radios," the device itself does not diagnose the degeneration; it is a treatment device.
No
The device description clearly states that the device is a physical interbody fusion device made from titanium alloy, produced by additive manufacturing, and supplied with surgical instruments. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate intervertebral body fusion in the cervical spine using bone graft and supplemental fixation. This is a surgical implant used in vivo (within the body) to treat a physical condition (degenerative disc disease).
- Device Description: The device is a physical implant (a cage) made of titanium alloy, designed to provide mechanical support and promote fusion.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a surgical implant, specifically an intervertebral body fusion device.
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 is 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 is 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 (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Tryptik® Ti is an anterior cervical interbody fusion device intended to provide mechanical support to the cervical spine and maintain adequate disc space until fusion occurs. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The Tryptik® Ti spacers are all made from medical grade titanium alloy and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The Tryptik® Ti interbody spacer has a monolithic design that incorporates solid and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant. The Tryptik® Ti spacers are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (from 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 the Tryptik® Ti spacers Static and Dynamic Axial Compression, Static and Dynamic Shear-compression and Static and Dynamic Torsion according to ASTM F2077-18 and Subsidence according to ASTM F2267-04. Results demonstrate comparable mechanical properties to the identified predicate devices. Mass loss was measured on post-test run out Tryptik® Ti worst-case specimens dynamically tested.
Additionally, cadaver lab implantation trials were conducted.
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.
Titanium C Anterior Cervical Cage (K171496), Tryptik® CA/CC (K091873 / K122366), EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, And EIT Cellular Titanium ALIF Cage (K170503 / K172888), Juliet® Ti (K153621)
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.
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April 6, 2020
Spineart Mr. Frank Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan les Quates Switzerland
Re: K200312
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 3, 2020 Received: February 6, 2020
Dear Mr. 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
1
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 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 (QS) 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 medical devices and radiation-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, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K200312 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 is 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 is 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)
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
| 510k | TRADITIONAL |
|---|---|
| Basis for submission | New 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: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | January 28, 2020 |
| Common Name | Intervertebral body fusion device |
| Trade Name | TRYPTIK®Ti Anterior Cervical Intervertebral Fusion Devices |
| 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: Tritanium C Anterior Cervical Cage (K171496) manufactured by |
| STRYKER SPINE | |
| Additional predicates: Tryptik® CA/CC (K091873 / K122366) manufactured by | |
| SPINEART; EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT | |
| Cellular Titanium TLIF Cages, And EIT Cellular Titanium ALIF Cage (K170503 / K172888) | |
| manufactured by EIT Emerging Implant Technologies GmbH and Juliet® Ti (K153621) manufactured by Spineart. | |
| 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 is 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 is 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. | |
| Description of the device | The Tryptik® Ti is an anterior cervical interbody fusion device intended to provide |
| mechanical support to the cervical spine and maintain adequate disc space until fusion | |
| occurs. The interbody device is a box-shaped spacer with a large central cavity that | |
| can receive bone graft intended to promote intervertebral fusion. The Tryptik® | |
| Ti spacers are all made from medical grade titanium alloy and are produced by | |
| additive manufacturing (SLM) according to ASTM F3001. Subsequently the | |
| spacer is machined (thread tapping) and polished. The Tryptik® Ti interbody | |
| spacer has a monolithic design that incorporates solid and porous structures | |
| along with superior and inferior rough surfaces intended to increase implant stability | |
| into the intervertebral space and bony integration throughout the implant. | |
| The Tryptik® Ti spacers are delivered sterile (gamma sterilization) and supplied | |
| with dedicated surgical instruments (reusable – provided non-sterile). Bacterial | |
| endotoxin testing on final, finished devices as specified in USP standard is used for | |
| pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. | |
| Technological | |
| characteristics compared | |
| to the predicate devices | The Tryptik® Ti spacers are available in various sizes, heights, footprints and lordosis |
| so as to adapt individual pathology and different patient's anatomical conditions. The | |
| Tryptik® Ti spacers are implanted via an anterior approach. These features are similar | |
| to those of the predicate devices (K171496, K091873 / K122366 and K170503 / | |
| K172888). | |
| The Tryptik® Ti spacers present the same monolithic design that incorporates solid | |
| and porous structures and are manufactured using the same manufacturing | |
| technology, i.e. additive manufacturing (SLM) as other cleared devices from Spineart. | |
| Discussion of Testing | The following non-clinical tests were conducted on the Tryptik® Ti spacers Static |
| and Dynamic Axial Compression, Static and Dynamic Shear-compression and | |
| Static and Dynamic Torsion according to ASTM F2077-18 and Subsidence | |
| according to ASTM F2267-04. Results demonstrate comparable mechanical | |
| properties to the identified predicate devices. Mass loss was measured on post-test | |
| run out Tryptik® Ti worst-case specimens dynamically tested. | |
| Additionally, cadaver lab implantation trials were conducted. | |
| Conclusion | Based on the design features, technological characteristics, feature comparisons, |
| indications for use, and non-clinical performance testing, the Tryptik® Ti spacers have | |
| demonstrated substantial equivalence to the identified predicate devices. |
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