(158 days)
K170675 Graftgun Universal Graft Delivery System, SurGenTec, LLC
K180937 Graftgun Universal Graft Delivery System, Surgentec, LLC
No
The device description and summary of performance studies focus on mechanical delivery of bone graft material and risk analysis, with no mention of AI or ML.
No
Explanation: A therapeutic device is one that treats or manages a disease or condition. This device is described as a "delivery system" for bone graft material to an orthopedic surgical site, and it is a "single use pre-sterilized, disposable system" for delivering the material. It does not exert any direct therapeutic action itself, but rather facilitates the delivery of another substance (bone graft material) that may have a therapeutic effect.
No
The device is described as a delivery system for bone graft material to a surgical site, and its function is to dispense this material. There is no mention of it being used for diagnostic purposes, such as identifying conditions or diseases.
No
The device description clearly outlines multiple physical components (Feeder, Reduction Sleeve, BC-Sleeve, Biologic Cartridge, Plunger, Gun) and describes a mechanical delivery mechanism (ratcheting mechanism). There is no mention of software as a component or function of the device.
Based on the provided information, the PREFERX Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site." This describes a device used during a surgical procedure to deliver material to a patient's body.
- Device Description: The description details a system for loading and dispensing bone graft material directly into a surgical site. It does not involve the analysis of samples taken from the body (like blood, urine, or tissue) outside of the body.
- Anatomical Site: The device is used at an "orthopedic surgical site," which is a location within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PREFERX Delivery System's function is purely for the physical delivery of material to a surgical site.
N/A
Intended Use / Indications for Use
The PREFERX Delivery System is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The PREFERX Delivery System is a single use pre-sterilized and disposable system consisting of a Feeder including a CC Body, Stand, and Funnel; a Reduction Sleeve; a BC-Sleeve and BC-Sleeve Cap, used to load the graft material into the Biologic Cartridge. The Biologic Cartridge contains and delivers the graft material to the surgical site. A Plunger expresses the graft material from the Biologic Cartridge through an actuating trigger on the Gun that advances the Plunger down the length of the Biologic Cartridge via a ratcheting mechanism. The system is designed such that the Biologic Cartridge can be filled with the desired graft material, attached to the Gun and Plunger for use, then removed and refilled during the same procedure.
The Biologic Cartridge does not have a Luer lock mechanism; the device does not require a needle or similar attachment; the Biologic Cartridge contents being dispensed directly from the tip of the Biologic Cartridge into the graft site.
The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in an outer paperboard carton.
The PREFERX Delivery System is a single use pre-sterilized, disposable system intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
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
operating room environment
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)
Performance data, including worst-case scenario, was provided in support of the substantial equivalence determinations. To further support substantial equivalence, we used the FMEA method to identify risks and characterize the severity and probability. The risks were reduced and are ranked as Acceptable. MD3 design control procedures, design verification and validation testing of the device were performed based on the results of the risk analysis.
Summary of Identified Risk and Verification Testing:
-
Potential Effect of Failure: Inflammation, redness and swelling, sometimes accompanied by heat and pain
- Potential Cause: Incompatible materials
- Action Taken: Biocompatibility Testing Certification included in DHR
-
Potential Effect of Failure: Graft is not applied to surgical site; graft must be applied another way - prolonged surgery
- Potential Cause: Gun is not properly assembled; Biologic Cartridge is plugged
- Action Taken: Perform visual/functionality test at incoming inspection; Perform burst and functionality test
-
Potential Effect of Failure: Fusion of bone may not occur, or heterotopic bone may form
- Potential Cause: Dimensions of cartridge are not correct resulting in incorrect volume of graft; Volume markings are not applied accurately; Teeth on plunger too small
- Action Taken: Perform visual/functionality test at incoming inspection; Records of compliance for dimensional certifications
-
Potential Effect of Failure: Patient becomes infected
- Potential Cause: No or inadequate sterilization method or cycle
- Action Taken: Certificate of Sterilization included in DHR; Sterilization validation Ink Test
-
Potential Effect of Failure: Chills to fever to swelling or sepsis
- Potential Cause: Endotoxins remain after sterilization
- Action Taken: Bacterial endotoxin test
-
Potential Effect of Failure: Delivery system is plugged from contents - prolonged surgery
- Potential Cause: Wrong material placed in cartridge
- Action Taken: The device has a fail-safe mechanism to avert breakage of cartridge.
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.
K170675 Graftgun Universal Graft Delivery System, SurGenTec, LLC
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.
K180937 Graftgun Universal Graft Delivery System, Surgentec, LLC
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).
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September 7, 2021
MD3 LLC Mary Ann Greenawalt Head of Quality 3650 Coral Ridge Drive. Suite 107 Coral Springs, Florida 33065
Re: K210997
Trade/Device Name: PREFERX Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: July 29, 2021 Received: July 30, 2021
Dear Mary Ann Greenawalt:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 mediation-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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
PREFERX Delivery System
Indications for Use (Describe)
The PREFERX Delivery System is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.
| 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: PREFERX™ Delivery System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | July 29, 2021 |
|---|---|
| Submitted By | MD3 LLC |
| 3650 Coral Ridge Drive Ste 107 | |
| Coral Springs, FL 33065 | |
| 1.561.703.2311 | |
| Primary Contact | Mary Ann Greenawalt |
| 3650 Coral Ridge Drive Ste 107 | |
| Coral Springs, FL 33065 | |
| 1.503.318.7722 | |
| maryann@md3inc.com | |
| Trade Name | PREFERX™ Delivery System |
| Common Name | Graft Delivery Device |
| Classification Name | Syringe, Piston |
| Class | II |
| Product Code | FMF |
| CFR Section | 21 CFR section 880.5860 |
| Device Panel | General and Plastic Surgery |
| Primary Predicate Device | K170675 Graftgun Universal Graft Delivery System, SurGenTec, LLC |
| Reference Device | K180937 Graftgun Universal Graft Delivery System, Surgentec, LLC |
| Device Description | The PREFERX Delivery System is a single use pre-sterilized and disposable system consisting of |
| a Feeder including a CC Body, Stand, and Funnel; a Reduction Sleeve; a BC-Sleeve and BC-Sleeve | |
| Cap, used to load the graft material into the Biologic Cartridge. The Biologic Cartridge contains and | |
| delivers the graft material to the surgical site. A Plunger expresses the graft material from the | |
| Biologic Cartridge through an actuating trigger on the Gun that advances the Plunger down the | |
| length of the Biologic Cartridge via a ratcheting mechanism. The system is designed such that the | |
| Biologic Cartridge can be filled with the desired graft material, attached to the Gun and Plunger for use, then removed and refilled during the same procedure. |
The Biologic Cartridge does not have a Luer lock mechanism; the device does not require a needle
or similar attachment; the Biologic Cartridge contents being dispensed directly from the tip of the
Biologic Cartridge into the graft site.
The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in an outer paperboard carton.
The PREFERX Delivery System is a single use pre-sterilized, disposable system intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. |
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| Materials | Clear Polycarbonate - ASTM F997-18
ABS GA850 (Acrylonitrile Butadiene Styrene) - USP Class VI
Stainless steel - ASTM F899-12b | | | |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Apply bone graft to an orthopedic surgical site in an operating room environment. | | | |
| Substantial
Equivalence Claimed
to Predicate Devices | The PREFERX Delivery System is substantially equivalent to the predicate devices in terms of
intended use, design, and materials used. | | | |
| Indications for Use | The PREFERX Delivery System is intended to be used for the delivery of hydrated allograft,
or synthetic bone graft material to an orthopedic surgical site. | | | |
| | GraftGun
Universal Graft
Delivery
(predicate) | PREFERX
Delivery System
(proposed) | Same/Similar/Different
as predicate | |
| | Sponsor/Submitter | SurGenTec | MD3 LLC | N/A |
| | FDA Regulation | 21 CFR 880.5860
Piston Syringe | 21 CFR 880.5860
Piston Syringe | Same |
| | FDA Product Code | FMF | FMF | Same |
| | FDA Classification | Class II | Class II | Same |
| | K Number | K170675 | TBD | N/A |
| Summary of the
technological
characteristics
compared to
predicate | Indications for Use | The GraftGun
Delivery System
is intended to be
used for the
delivery of
hydrated
allograft,
autograft, or
synthetic bone
graft material to
an orthopedic
surgical
site. | The PREFERX
Delivery System is
intended to be used
for the delivery of
hydrated allograft,
autograft, or
synthetic bone graft
material to an
orthopedic surgical
site. | Same |
| | Single Use | Yes | Yes | Same |
| | Sterilization Method | Gamma
irradiation to
SAL of 10-6 | Gamma irradiation
to SAL of 10-6 | Same |
| | Patient Contact
Material (transient use
in surgical suite) | Medical Grade:
• Polycarbonate
• ABS
• Polypropylene
• Stainless Steel
- 316L, 316F,
304H, 304HC
• Radiopaque ring | Medical Grade:
• Polycarbonate
• ABS | The proposed device is
comprised of fewer patient
contacting materials than the
predicate device. The
absence of patient contacting
material: polypropylene and a
stainless-steel radiopaque
ring is not a significant
change in materials or design
and does not raise questions
of safety and effectiveness.
All component materials have
a long history of use in
medical devices. Both
products use ABS &
polycarbonate. |
| | Volume | Up to 7.5cc in
graft tube | Up to 5.0cc in graft
tube | If more graft is needed the
PREFERX cartridge may be
reloaded during the same
procedure. |
| | Operating Principle | Graft material
expressed from
graft
tube via a plunger,
operated by a
ratchet-actuated
handle. Material
expressed from
graft tube to graft
site. | Graft material
expressed from
graft tube via a
plunger, operated by
a ratchet-actuated
handle. Material
expressed from graft
tube to graft site. | Same |
| | Performance data, including worst-case scenario, was provided in support of the substantial
equivalence determinations. To further support substantial equivalence, we used the FMEA method
to identify risks and characterize the severity and probability. The risks were reduced and are ranked
as Acceptable. MD3 design control procedures, design verification and validation testing of the device
were performed based on the results of the risk analysis. The following summarizes the identified
risks and the applicable testing that was performed.
Summary of Identified Risk and Verification Testing | | | |
| | Potential Effect of Failure | Potential Cause | | Action Taken |
| Non-clinical Test
Summary | Inflammation, redness and
swelling, sometimes
accompanied by heat and pain | Incompatible materials | | Biocompatibility Testing
Certification included in DHR |
| | Graft is not applied to surgical
site; graft must be applied
another way - prolonged
surgery | Gun is not properly
assembled
Biologic Cartridge is plugged | | Perform visual/functionality
test at incoming inspection
Perform burst and
functionality test |
| | Fusion of bone may not occur,
or heterotopic bone may form | Dimensions of cartridge are
not correct resulting in
incorrect volume of graft
Volume markings are not
applied accurately
Teeth on plunger too small | | Perform visual/functionality
test at incoming inspection
Records of compliance for
dimensional certifications |
| | Patient becomes infected | No or inadequate sterilization
method or cycle | Certificate of Sterilization
included in DHR
Sterilization validation
Ink Test | |
| | Chills to fever to swelling or
sepsis | Endotoxins remain after
sterilization | Bacterial endotoxin test | |
| | Delivery system is plugged
from contents - prolonged
surgery | Wrong material placed in
cartridge | The device has a fail-safe
mechanism to avert breakage
of cartridge. | |
| Clinical Test Summary | No clinical studies were performed | | | |
| Conclusion: | MD3 LLC considers the PREFERX Delivery System to be as safe and effective and perform at least
as well as the legally marketed predicate device when used as intended. The systems, predicates
and proposed, are designed so that the Biologic Cartridge can be filled with the desired graft material,
attached to the Gun and the Plunger, and delivered to the orthopedic surgical site. Substantial
equivalence to the predicate device is based upon the similarities in design, principles of operation,
technology, materials and indications for use. | | | |
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