(92 days)
No
The summary describes a manually operated mechanical device for delivering bone graft material and does not mention any AI or ML components or functionalities.
No
The device is described as a delivery system for bone graft materials, facilitating their placement in surgical sites, rather than directly treating a disease or condition itself.
No
The device is a delivery system for bone graft materials, facilitating their placement in surgical sites rather than performing any diagnostic function.
No
The device description clearly outlines physical components (delivery cannula, delivery plunger, etc.) and describes it as a manually operated hand-held device, indicating it is a hardware device, not software-only.
Based on the provided information, the LITe® BIO Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites." This describes a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description details a manually operated hand-held device for delivering bone graft material during surgery. This aligns with a surgical instrument, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information. The device's function is purely mechanical delivery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LITe® BIO Delivery System does not fit this description.
N/A
Intended Use / Indications for Use
The LITe® BIO Delivery System is intended to deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The LITe® BIO Delivery System is a manually operated hand-held device used to facilitate delivery of bone graft material to all orthopedic surgical sites. The LITe® BIO Delivery System consists of a delivery cannula, a delivery plunger, a delivery plunger tip, a loading syringe, and a delivery handle. The cannula is filled with the physician's choice of bone graft material and is then delivered to the intended surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all orthopedic surgical sites.
Indicated Patient Age Range
Not Found
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)
Testing was conducted to demonstrate performance as intended and included the following bench testing:
•Functional testing (delivery of graft material through cannula)
•Life cycle testing
•Cantilever bending of cannula
•Radial compression of cannula
•Retention strength test of cannula
•Connection strength test of cannula to loading funnel
The testing verifies that the subject device is substantially equivalent to other currently marketed bone graft delivery systems and any technological differences do not raise any new issues regarding 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.
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2016
Stryker Corporation Ms. Meriam Gabera Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K160978
Trade/Device Name: Lite Bio Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: April 6, 2016 Received: April 7, 2016
Dear Ms. Gabera:
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 of medical devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160978
Device Name LITe® BIO Delivery System
Indications for Use (Describe)
The LITe® BIO Delivery System is intended to deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites.
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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| 510(k) Summary as required by 21CFR§807.92(c): LITe® BIO Delivery System | |
|---|---|
| Submitter | Stryker Spine |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Contact Person | Meriam Gabera, MS |
| Senior Regulatory Affairs Specialist | |
| Phone: 201-749-8043 | |
| Fax: 201-831-3000 | |
| E-mail: meriam.gabera@stryker.com | |
| Date Prepared | July 1, 2016 |
| Trade Name | LITe® BIO Delivery System |
| Common Name | Syringe, piston |
| Proposed Class | Class II |
| Classification Name, | |
| Codification | Piston syringe, 21 CFR § 880.5860 |
| Product Codes | FMF |
| Predicate Devices | Primary Predicate: |
| • Arthrex Mixing and Delivery System - K121124 | |
| Additional Predicates: | |
| • Biomet Graft Delivery Syringes - K140710 | |
| • NovaBone MIS Cartridge Delivery System - K112773 | |
| Reference Devices: | |
| • Imbibe Bone Marrow Aspiration Syringe – K023074 | |
| • Aero-AL Lumbar Cage System – K133328 | |
| • Aero-C Cervical Cage System – K152532 | |
| Device Description | The LITe® BIO Delivery System is a manually operated hand-held device |
| used to facilitate delivery of bone graft material to all orthopedic | |
| surgical sites. The LITe® BIO Delivery System consists of a delivery | |
| cannula, a delivery plunger, a delivery plunger tip, a loading syringe, and | |
| a delivery handle. The cannula is filled with the physician's choice of | |
| bone graft material and is then delivered to the intended surgical site. | |
| Indications for Use | The LITe® BIO Delivery System is intended to deliver autograft, allograft, |
| or synthetic bone graft materials to all orthopaedic surgical sites. | |
| Summary of | |
| Technological | |
| Characteristics | The LITe® BIO Delivery System shares similar materials, design, and |
| fundamental scientific technologies as the predicate devices. An | |
| assessment of the technological differences was completed and the | |
| following differences were identified: | |
| • The design of the primary predicate system allows for | |
| mixing/preparing the bone graft mixture within the device as | |
| opposed to using an external surgical dish for preparing the | |
| bone graft material. | |
| while the subject device is supplied with both sterile, single use | |
| devices and non-sterile, reusable instruments. | |
| The comparison of the LITe® BIO Delivery System against the primary | |
| predicate system demonstrated that the identified design differences do | |
| not impact the functionality or performance of the subject system, | |
| supporting the claim of substantial equivalence. | |
| Summary of | |
| Performance Data | Testing was conducted to demonstrate performance as intended and |
| included the following bench testing: | |
| •Functional testing (delivery of graft material through cannula) | |
| •Life cycle testing | |
| •Cantilever bending of cannula | |
| •Radial compression of cannula | |
| •Retention strength test of cannula | |
| •Connection strength test of cannula to loading funnel | |
| The testing verifies that the subject device is substantially equivalent to | |
| other currently marketed bone graft delivery systems and any | |
| technological differences do not raise any new issues regarding safety | |
| and effectiveness. | |
| Conclusion | Based upon a comparison of intended use, technological characteristics, |
| and device performance in the non-clinical testing listed above, the | |
| LITe® BIO Delivery System has demonstrated substantial equivalence to | |
| the identified predicate device systems. |
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