(84 days)
No
The device description and performance studies focus on mechanical delivery of bone graft material, with no mention of AI/ML capabilities or data processing.
No.
The device is a delivery system for bone graft material and does not directly provide therapy.
No.
The device is described as a delivery system for bone graft material to a surgical site, with no mention of diagnostic capabilities, analysis of patient data, or generation of diagnostic information.
No
The device description clearly outlines physical components (syringe barrel, plunger, funnel reservoir) and bench testing for physical properties (pressure-force, leak test, shaft strength), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of hydrated allograft or autograft to an orthopedic surgical site." This describes a surgical tool for delivering material into the body during a procedure.
- Device Description: The description details a syringe-like device for physically delivering bone graft material. It focuses on the mechanical aspects of delivery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs are used for testing blood, urine, tissue samples, etc.
- Anatomical Site: The device is used at an "orthopedic surgical site," which is a location within the body during surgery.
- Performance Studies: The performance studies mentioned are bench evaluations for simulated use, pressure-force, leak test, and shaft strength. These are typical tests for a surgical delivery device, not for an IVD which would involve analytical and clinical performance studies related to diagnostic accuracy.
In summary, the Bi-Portal Bone Graft Delivery Device is a surgical instrument designed for the physical delivery of material during an orthopedic procedure, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Bi-Portal Bone Graft Delivery Device is intended to be used for the delivery of hydrated allograft or autograft to an orthopedic surgical site.
Product codes
FMF
Device Description
The Bi-Portal Bone Graft Delivery Device is comprised of a 21.0 cm length rectangular syringe barrel for surgical site access and bone graft material delivery; a compatible syringe plunger for pushing the allograft or autograft into the operative site; and, an attachable funnel reservoir for loading prepared material. The barrel has an 8.0 mm by 12.0 mm closed-end tapered distal shaft with a pair of longitudinal bilateral ejection holes near the distal end for material effusion into the surgical space. The barrel can be partially filled with up to 4.0 cc of material and refilled in-situ using the attachable funnel.
When used as an ancillary device to orthopedic surgical procedures that require the placement of autograft or allograft, the Bi-Portal Device can deliver a prepared amount of material. There are no luer lock components to the bi-portal design is intended to result in graft material effusion through the two laterally placed sideholes. This allows the material to be selectively placed within the surgical space adjacent to the Device barrel tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic surgical site
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 has been performed to support safety and effectiveness to the predicate and to demonstrate performance as intended. The Bi-Portal Bone Graft Delivery Device was verified by bench evaluation for simulated use, pressure-force, leak test and shaft strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2014
Spinal Surgical Strategies, LLC % Mr. Tim Reeves Regulatory Consultant 999 Driver Way Incline Village, Nevada 89451
Re: K142661
Trade/Device Name: Bi-Portal Bone Graft Delivery Device Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: September 15, 2014 Received: September 18, 2014
Dear Mr. Reeves:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K142661
Device Name: Bi-Portal Bone Graft Delivery Device
Indications for Use:
The Bi-Portal Bone Graft Delivery Device is intended to be used for the delivery of hydrated allograft or autograft to an orthopedic surgical site.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
3
Spinal Surgical Strategies, LLC
Bi-Portal Bone Graft Delivery Device – K142661 Premarket Notification [510(k)] Submission 009_510k Summary
Image /page/3/Picture/3 description: The image is a logo with a circular background that fades from white to light gray. The main element is a stylized, abstract design composed of interconnected, rounded shapes in shades of blue and gray. The shapes are arranged in a way that resembles a spine or a series of vertebrae. The text "Spinal Surgical Strategies" is written in a circular path around the bottom of the logo.
Tab 5
Premarket Notification [510(k)] Summary
| Submission Date: | September 15, 2014 | |
|---|---|---|
| Trade Name: | Bi-Portal Bone Graft Delivery Device | |
| Common Name: | Piston Syringe | |
| Classification: | 21 CFR 880.5860; Class II | |
| Product Code: | FMF | |
| Manufacturer's Name: | ||
| Address: | Spinal Surgical Strategies, LLC | |
| 999 Driver Way | ||
| Incline Village, NV 89451 | ||
| Corresponding Official: | ||
| Title: | ||
| Address: | Tim Reeves | |
| Regulatory Consultant | ||
| c/o Spinal Surgical Strategies | ||
| 999 Driver Way | ||
| Incline Village, NV 89451 | ||
| Telephone: | 408-702-7259 | |
| Predicate Device: | K121476 - Infill™ Graft Delivery System | |
| (Pinnacle Spine Group, LLC) |
Indication for Use:
The Bi-Portal Bone Graft Delivery Device is intended to be used for the delivery of hydrated allograft or autograft to an orthopedic surgical site.
Device Description:
The Bi-Portal Bone Graft Delivery Device is comprised of a 21.0 cm length rectangular syringe barrel for surgical site access and bone graft material delivery; a compatible
4
Spinal Surgical Strategies, LLC
Bi-Portal Bone Graft Delivery Device - K142661 Premarket Notification [510(k)] Submission 009_510k Summary
syringe plunger for pushing the allograft or autograft into the operative site; and, an attachable funnel reservoir for loading prepared material. The barrel has an 8.0 mm by 12.0 mm closed-end tapered distal shaft with a pair of longitudinal bilateral ejection holes near the distal end for material effusion into the surgical space. The barrel can be partially filled with up to 4.0 cc of material and refilled in-situ using the attachable funnel.
When used as an ancillary device to orthopedic surgical procedures that require the placement of autograft or allograft, the Bi-Portal Device can deliver a prepared amount of material. There are no luer lock components to the bi-portal design is intended to result in graft material effusion through the two laterally placed sideholes. This allows the material to be selectively placed within the surgical space adjacent to the Device barrel tip.
Performance Testing:
Testing has been performed to support safety and effectiveness to the predicate and to demonstrate performance as intended. The Bi-Portal Bone Graft Delivery Device was verified by bench evaluation for simulated use, pressure-force, leak test and shaft strength.
Biocompatibility:
The Bi-Portal Bone Graft Delivery Device is composed of sterile medical grade plastic components, which has passed all of the recommended biocompatibility test requirements of ISO 10993-1.
Sterilization and Packaging:
Sterilization validation, package integrity, distribution and shelf life studies were completed and documented for the Bi-Portal Bone Graft Delivery Device. Studies were conducted in accordance with the applicable recommendations from the FDA Piston Syringe and 510(k) Guidance documents, and the applicable recognized standards. All test acceptance criteria were met.
The Device is labeled sterile, for single-use only. The packaging and contents are ethylene oxide sterilized by a validated process to a Sterility Assurance Level (SAL) of 10° per ANSVAAMI/ISO 11135-1 for ethylene oxide sterilization of health care products Accelerated aging was completed to support a labeled shelf life of 12 months.
Substantial Equivalence
5
Spinal Surgical Strategies, LLC
Bi-Portal Bone Graft Delivery Device - K142661 Premarket Notification [510(k)] Submission 009_510k Summary
The Bi-Portal Bone Graft Delivery Device was evaluated in accordance with 21 CFR 807.87(d - g) to verify substantial equivalence. The intended use of the Device is the same as the predicate device. The comparison table provides an overview of the key features, indications and technological comparisons of the 510(k) predicate. Predicate device information has been obtained through the respective 510(k) summary and labeling information provided by the manufacturer. These comparisons support substantial equivalence for the technology, function, mechanism of action and intended use to the predicate. There are no new type safety or effectiveness questions for the Bi-Portal Bone Graft Delivery Device to the stated indication for use.
Comparison Table: Substantial Equivalence Comparison of Bi-Portal Bone Graft Delivery Device to the Predicate Device for Bone Graft Delivery
| Manufacturer;
Device | Spinal Surgical Specialties;
Bi-Portal Bone Graft Delivery
Device | Pinnacle Spine Group; Infill™
Graft Delivery System (K121476) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | | |
| Product Code;
Common Name | FMF; Piston Syringe | |
| Classification | Class II; 21 CFR 880.5860 | |
| Indication for Use | The Bi-Portal Bone Graft Delivery
Device is intended to be used for
the delivery of hydrated allograft
or autograft to an orthopedic
surgical site. | The InFill™ Graft Delivery System is
intended to be used for the delivery of
hydrated allograft, autograft or
synthetic bone graft material to an
orthopedic surgical site. |
| Intended Use | Bone graft delivery to an orthopedic surgical site. | |
| Mechanism of
Action | Graft Material dispersed from device tip by depressing the plunger. | |
| Graft Injection | Bilateral sidehole delivery into
surgical space. | Endhole delivery into surgical space
and instrumentation. |
| Syringe Material | Biocompatible Medical Grade Plastics | |
| Syringe
Components | Barrel, Plunger and Funnel | Barrel, Plunger, Stylet, Cannula
extension and Funnel |
| Bone Graft Exit
Hole Diameter | Two sideholes: 5.6 mm x 14.8 mm | Single cannula endhole: 8.0 mm |
| Recommended
Graft Volume | Up to 4.0 cc in Barrel | Up to 4.0 cc in Cannula |
| Sterility | Yes; Single Use Only | |