(84 days)
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 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.
The provided text does NOT describe a study that uses AI or machine learning, nor does it present acceptance criteria and reported device performance in the context of such a study.
Instead, the document is a 510(k) premarket notification summary for a medical device called the "Bi-Portal Bone Graft Delivery Device." It details the device's indications for use, description, and performance testing to demonstrate substantial equivalence to a predicate device, as required by the FDA.
Here's a breakdown of the information that can be extracted, and what cannot, based on your request:
Information NOT available in the document (as it pertains to AI/ML studies):
- A table of acceptance criteria and the reported device performance (in the context of AI/ML): This document describes performance testing for a physical medical device (bone graft delivery device), focusing on mechanical properties, sterilization, and biocompatibility, not AI/ML performance metrics like sensitivity, specificity, or AUC.
- Sample sized used for the test set and the data provenance: Not applicable to an AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML study.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information that CAN be extracted, though not in the context of AI/ML:
The document describes the device's performance testing to support its safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance (Non-AI/ML context):
The document states: "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."
And: "All test acceptance criteria were met."
While specific numerical acceptance criteria and detailed performance results for each test (simulated use, pressure-force, leak test, shaft strength) are not provided in this summary, the general statement confirms that the device met internal acceptance criteria for these tests.
Regarding 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." (Meaning, it meets the acceptance criteria of ISO 10993-1).
Regarding sterilization and packaging: "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." This implies meeting acceptance criteria for Sterility Assurance Level (SAL) of 10⁻⁶ per ANSVAAMI/ISO 11135-1 and supporting a labeled shelf life of 12 months based on accelerated aging.
2. Type of Ground Truth Used (Non-AI/ML context):
The "ground truth" in this context refers to the established standards and methods for testing physical medical devices. This includes:
- Bench evaluation for simulated use, pressure-force, leak test, and shaft strength. The "truth" here is determined by engineering specifications and physical measurements.
- Biocompatibility testing against ISO 10993-1 standards. The "truth" is whether the materials meet the criteria defined by this international standard for biological safety.
- Sterilization validation and packaging studies according to FDA guidance and recognized standards like ANSVAAMI/ISO 11135-1. The "truth" is achieving the specified Sterility Assurance Level and maintaining packaging integrity and shelf life.
In summary, this document is a regulatory submission for a physical medical device and does not contain information relevant to an AI/ML study, its acceptance criteria, or performance in that domain.
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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
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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
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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)
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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, LLC999 Driver WayIncline Village, NV 89451 | |
| Corresponding Official:Title:Address: | Tim ReevesRegulatory Consultantc/o Spinal Surgical Strategies999 Driver WayIncline 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
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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
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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 DeliveryDevice | 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 DeliveryDevice is intended to be used forthe delivery of hydrated allograftor autograft to an orthopedicsurgical site. | The InFill™ Graft Delivery System isintended to be used for the delivery ofhydrated allograft, autograft orsynthetic bone graft material to anorthopedic surgical site. |
| Intended Use | Bone graft delivery to an orthopedic surgical site. | |
| Mechanism ofAction | Graft Material dispersed from device tip by depressing the plunger. | |
| Graft Injection | Bilateral sidehole delivery intosurgical space. | Endhole delivery into surgical spaceand instrumentation. |
| Syringe Material | Biocompatible Medical Grade Plastics | |
| SyringeComponents | Barrel, Plunger and Funnel | Barrel, Plunger, Stylet, Cannulaextension and Funnel |
| Bone Graft ExitHole Diameter | Two sideholes: 5.6 mm x 14.8 mm | Single cannula endhole: 8.0 mm |
| RecommendedGraft Volume | Up to 4.0 cc in Barrel | Up to 4.0 cc in Cannula |
| Sterility | Yes; Single Use Only |
§ 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).