(87 days)
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Not Found
No
The provided text describes a physical medical device (cervical interbody fusion cage) made of PEEK and titanium markers. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies section refers to conformance to a guidance document for intervertebral body fusion devices, not software performance metrics.
Yes
The device, TRYPTIK®ca cages, is used to facilitate intervertebral body fusion in the cervical spine for patients with degenerative disc disease, which is a therapeutic intervention.
No
This device, TRYPTIK®ca, is an intervertebral body fusion device indicated for treating degenerative disc disease by facilitating fusion, not for diagnosing the condition itself.
No
The device description explicitly states it is a physical interbody fusion device made of PEEK and titanium, intended for surgical implantation.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the TRYPTIK®ca cages are "cervical interbody fusion devices made of PEEK OPTIMA" and are implanted into the body to facilitate spinal fusion.
- Intended Use: The intended use is to treat degenerative disc disease by facilitating intervertebral body fusion in the cervical spine. This is a surgical procedure involving an implanted device, not a diagnostic test performed on a sample outside the body.
Therefore, the TRYPTIK®ca cages are a medical device used for surgical treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TRYPTIK®ca cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. 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
TRYPTIK ca of cervical interbody fusion devices made of PEEK OPTIMA conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. TRYPTIK ca devices are designed for an anterior approach. All devices are supplied sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, C3 to C7 disc levels
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
TRYPTIK ca cervical interbody fusion devices conform to Class II Special Controls Guidance Document: Intervertebral Body Fusion Device- Document issued on: June 12, 2007
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
510(k) Summary of Safety and EFFECTIVENESS
SEP 1 8 2009
As required by section 807.92(c)
'
.
| SPINEART | |||
|---|---|---|---|
| Submitter | International Center Cointrin 20 route de pré-bois | ||
| CP1813 | |||
| 1215 GENEVA 15 | |||
| SWITZERLAND | |||
| Contacts | Franck PENNESI Director of Industry & Quality | ||
| Phone : +41 22 799 40 25 | |||
| Fax : +41 22 799 40 26 | |||
| Mail : fpennesi@spineart.ch | |||
| Regulatory contact : Dr Isabelle DRUBAIX (Idée | |||
| Consulting) idrubaix@nordnet.fr | |||
| Preparation date | June 9, 2009 | ||
| Trade Name | TRYPTIK ca | ||
| Classification Name | Intervertebral body fusion device- Cervical | ||
| Class | II | ||
| Product Code | ODP | ||
| CFR section | 888.3080 | ||
| Device panel | Orthopedic | ||
| Legally marketed | |||
| predicate devices | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | ||
| (P000028) manufactured by MEDTRONIC, BAK/C | |||
| CERVICAL INTERBODY FUSION DEVICE (P980048) | |||
| manufactured by ZIMMER SPINE, CRYSTAL (K073351) | |||
| manufactured by SPINAL ELEMENTS, INC | |||
| Description | TRYPTIK ca of cervical interbody fusion devices made | ||
| of PEEK OPTIMA conforming ASTM F2026. Markers | |||
| made of titanium conforming ASTM F136 are used to | |||
| visualize the position of the implant in the disc space. | |||
| TRYPTIK ca devices are designed for an anterior | |||
| approach. All devices are supplied sterile. |
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1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
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1
.
.
| | Intended Use | TRYPTIK®ca cages are indicated for use in skeletally
mature patients with degenerative disc disease (DDD)
of the cervical spine with accompanying radicular
symptoms at one disc level. DDD is defined as
discogenic pain with degeneration of the disc
confirmed by patient history and radiographic studies.
TRYPTIK®ca are used to facilitate intervertebral body
fusion in the cervical spine at the C3 to C7 disc levels
using autograft bone. TRYPTIK®ca are to be used with
supplemental fixation. Patients should have at least
six (6) weeks of non-operative treatment prior to
treatment with an intervertebral cage |
|--|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance data | TRYPTIK ca cervical interbody fusion devices conform
to Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device- Document issued
on: June 12, 2007 |
| | Substantial
equivalence | TRYPTIK cervical interbody fusion device is
substantially equivalent to its predicate devices in
terms of intended use, material, design, mechanical
properties and function. |
and the comments of the comments of the comments of
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:
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:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is smaller than the caduceus symbol.
SEP 1 8 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Spineart % Franck Pennesi International Center Cointrin 20 Route de Pre-Bois, CP1813 Geneva Switzerland 1215
Re: K091873
Trade/Device Name: TRYPTIK CA Anterior Intersomatic Cervical Cage Regulation Number: 21 CFR 888,3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: ODP
Dated: June 22, 2009
Received: June 23, 2009
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. 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.
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 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.
3
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Voubeu Muchm
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): Device Name: TRYPTIK ca Indications for Use:
TRYPTIK®ca cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage
Prescription Use | ★ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kareem S. Burney for MxM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091873
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