Who is the manufacturer of PreferX Delivery System?

Md3, LLC filed the 510(k) submission for PreferX Delivery System (K210997).

What is the FDA product code for PreferX Delivery System?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for PreferX Delivery System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PreferX Delivery System?

Graftgun Universal Graft Delivery System (K170675).

Who can help prepare an FDA 510(k) submission like PreferX Delivery System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PreferX Delivery System

K210997 · Md3, LLC · FMF · Sep 7, 2021 · General Hospital

Device Facts

Record ID	K210997
Device Name	PreferX Delivery System
Applicant	Md3, LLC
Product Code	FMF · General Hospital
Decision Date	Sep 7, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2

Intended 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.

Device Story

Manual orthopedic surgical instrument; delivers hydrated allograft, autograft, or synthetic bone graft material. System components: feeder (body, stand, funnel), reduction sleeve, biologic cartridge, plunger, and ratcheting gun. User fills biologic cartridge with graft material, attaches to gun/plunger assembly; trigger mechanism advances plunger to express graft from cartridge tip directly into surgical site. Single-use, disposable, pre-sterilized. Used in operating room by surgeons. Enables precise graft placement; cartridge can be removed and refilled during procedure if additional volume is required.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility, burst/functionality testing, and sterilization validation.

Technological Characteristics

Piston syringe mechanism; manual ratchet-actuated handle. Materials: Clear Polycarbonate (ASTM F997-18), ABS GA850 (USP Class VI), Stainless steel (ASTM F899-12b). Single-use; gamma irradiation sterilization (SAL 10^-6). No electronic components or software.

Indications for Use

Indicated for delivery of hydrated allograft, autograft, or synthetic bone graft material to orthopedic surgical sites.

Regulatory Classification

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.

Predicate Devices

Graftgun Universal Graft Delivery System (K170675)

Reference Devices

Graftgun Universal Graft Delivery System (K180937)

Related Devices

K160978 — LITe BIO Delivery System · Stryker Corporation · Jul 8, 2016
K200606 — O-Genesis Graft Delivery System · Orthofix, Inc. · May 1, 2020
K170675 — Graftgun Universal Graft Delivery System · SurGenTec, LLC · Jul 19, 2017
K221737 — InstaFill Graft Delivery System, SIGNIFY Bioactive · Globus Medical, Inc. · Aug 11, 2022
K140710 — BIOMET GRAFT DELIVERY SYRINGES · Biomet Spine (Aka Ebi, LLC) · Sep 4, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION". 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210997 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) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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. | {4}------------------------------------------------ | 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. | | | | {5}------------------------------------------------ {6}------------------------------------------------ -end-