(158 days)
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.
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.
The provided document is a 510(k) Summary for the PREFERX Delivery System. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain explicit acceptance criteria tables for performance metrics or detailed study results demonstrating that the device meets such criteria.
The "Preformance data" section on page 4 primarily focuses on a risk analysis via FMEA and verification testing related to identified risks, rather than establishing specific performance acceptance criteria for typical AI/ML device metrics like sensitivity, specificity, or AUC. The device described, the PREFERX Delivery System, is a mechanical system for delivering bone graft material, not an AI/ML diagnostic or predictive tool.
Therefore, many of the requested elements for an AI/ML device are not applicable or present in this document. I will extract the information that is available and note when information is not provided.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
As the PREFERX Delivery System is a mechanical device for delivering bone graft material, and not an AI/ML device, the typical performance metrics like sensitivity, specificity, or AUC with corresponding acceptance criteria are not relevant or reported in this document.
Instead, the document details a series of potential risks and the "Action Taken" (verification tests performed) to mitigate those risks, which implicitly serve as a form of performance validation for the identified failure modes.
| Potential Effect of Failure | Potential Cause | Action Taken (Verification Test Performed) |
|---|---|---|
| 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. |
Note: The "reported device performance" is not quantified with specific numerical targets for these actions (e.g., "burst strength > X MPa"). Instead, the document states that "Performance data, including worst-case scenario, was provided in support of the substantial equivalence determinations. ... 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." This implies that the tests were performed and the device passed the requirements, but the specific quantitative outcomes are not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The general nature of the "Action Taken" suggests a series of engineering and laboratory tests rather than a clinical "test set" in the context of AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. This device is a bone graft delivery system, not an AI/ML diagnostic tool requiring expert consensus for ground truth on medical data. The ground truth for the verification tests would be established by standard engineering and biocompatibility testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI/ML performance evaluation, which is not the context here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this type of mechanical device and was not performed. The document explicitly states: "No clinical studies were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the PREFERX Delivery System is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the verification tests (e.g., biocompatibility, functionality, sterilization), the "ground truth" would be established by standard laboratory testing protocols and certifications against recognized industry standards (e.g., ASTM, USP, ISO). For example:
- Biocompatibility: Tests conform to ISO 10993 standards.
- Sterilization: Certification of Sterilization to a Sterility Assurance Level (SAL) of 10^-6.
- Dimensional accuracy: Compliance with specified engineering drawings and measurements.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided as there is no "training set" for this device.
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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
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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 LLC3650 Coral Ridge Drive Ste 107Coral Springs, FL 330651.561.703.2311 |
| Primary Contact | Mary Ann Greenawalt3650 Coral Ridge Drive Ste 107Coral Springs, FL 330651.503.318.7722maryann@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 ofa Feeder including a CC Body, Stand, and Funnel; a Reduction Sleeve; a BC-Sleeve and BC-SleeveCap, used to load the graft material into the Biologic Cartridge. The Biologic Cartridge contains anddelivers the graft material to the surgical site. A Plunger expresses the graft material from theBiologic Cartridge through an actuating trigger on the Gun that advances the Plunger down thelength of the Biologic Cartridge via a ratcheting mechanism. The system is designed such that theBiologic 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 needleor similar attachment; the Biologic Cartridge contents being dispensed directly from the tip of theBiologic 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 F997-18ABS GA850 (Acrylonitrile Butadiene Styrene) - USP Class VIStainless steel - ASTM F899-12b | |||
|---|---|---|---|---|
| Intended Use | Apply bone graft to an orthopedic surgical site in an operating room environment. | |||
| SubstantialEquivalence Claimedto Predicate Devices | The PREFERX Delivery System is substantially equivalent to the predicate devices in terms ofintended 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. | |||
| GraftGunUniversal GraftDelivery(predicate) | PREFERXDelivery System(proposed) | Same/Similar/Differentas predicate | ||
| Sponsor/Submitter | SurGenTec | MD3 LLC | N/A | |
| FDA Regulation | 21 CFR 880.5860Piston Syringe | 21 CFR 880.5860Piston Syringe | Same | |
| FDA Product Code | FMF | FMF | Same | |
| FDA Classification | Class II | Class II | Same | |
| K Number | K170675 | TBD | N/A | |
| Summary of thetechnologicalcharacteristicscompared topredicate | Indications for Use | The GraftGunDelivery Systemis intended to beused for thedelivery ofhydratedallograft,autograft, orsynthetic bonegraft material toan orthopedicsurgicalsite. | The PREFERXDelivery System isintended to be usedfor the delivery ofhydrated allograft,autograft, orsynthetic bone graftmaterial to anorthopedic surgicalsite. | Same |
| Single Use | Yes | Yes | Same | |
| Sterilization Method | Gammairradiation toSAL of 10-6 | Gamma irradiationto SAL of 10-6 | Same | |
| Patient ContactMaterial (transient usein surgical suite) | Medical Grade:• Polycarbonate• ABS• Polypropylene• Stainless Steel- 316L, 316F,304H, 304HC• Radiopaque ring | Medical Grade:• Polycarbonate• ABS | The proposed device iscomprised of fewer patientcontacting materials than thepredicate device. Theabsence of patient contactingmaterial: polypropylene and astainless-steel radiopaquering is not a significantchange in materials or designand does not raise questionsof safety and effectiveness.All component materials havea long history of use inmedical devices. Bothproducts use ABS &polycarbonate. | |
| Volume | Up to 7.5cc ingraft tube | Up to 5.0cc in grafttube | If more graft is needed thePREFERX cartridge may bereloaded during the sameprocedure. | |
| Operating Principle | Graft materialexpressed fromgrafttube via a plunger,operated by aratchet-actuatedhandle. Materialexpressed fromgraft tube to graftsite. | Graft materialexpressed fromgraft tube via aplunger, operated bya ratchet-actuatedhandle. Materialexpressed from grafttube to graft site. | Same | |
| Performance data, including worst-case scenario, was provided in support of the substantialequivalence determinations. To further support substantial equivalence, we used the FMEA methodto identify risks and characterize the severity and probability. The risks were reduced and are rankedas Acceptable. MD3 design control procedures, design verification and validation testing of the devicewere performed based on the results of the risk analysis. The following summarizes the identifiedrisks and the applicable testing that was performed.Summary of Identified Risk and Verification Testing | ||||
| Potential Effect of Failure | Potential Cause | Action Taken | ||
| Non-clinical TestSummary | Inflammation, redness andswelling, sometimesaccompanied by heat and pain | Incompatible materials | Biocompatibility TestingCertification included in DHR | |
| Graft is not applied to surgicalsite; graft must be appliedanother way - prolongedsurgery | Gun is not properlyassembledBiologic Cartridge is plugged | Perform visual/functionalitytest at incoming inspectionPerform burst andfunctionality test | ||
| Fusion of bone may not occur,or heterotopic bone may form | Dimensions of cartridge arenot correct resulting inincorrect volume of graftVolume markings are notapplied accuratelyTeeth on plunger too small | Perform visual/functionalitytest at incoming inspectionRecords of compliance fordimensional certifications | ||
| Patient becomes infected | No or inadequate sterilizationmethod or cycle | Certificate of Sterilizationincluded in DHRSterilization validationInk Test | ||
| Chills to fever to swelling orsepsis | Endotoxins remain aftersterilization | Bacterial endotoxin test | ||
| Delivery system is pluggedfrom contents - prolongedsurgery | Wrong material placed incartridge | The device has a fail-safemechanism to avert breakageof 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 leastas well as the legally marketed predicate device when used as intended. The systems, predicatesand 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. Substantialequivalence to the predicate device is based upon the similarities in design, principles of operation,technology, materials and indications for use. |
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-end-
§ 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).