(54 days)
Not Found
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, not a therapeutic agent itself. It facilitates a medical procedure rather than providing direct therapy.
No
The device is described as a delivery system for bone graft material to an orthopedic surgical site. Its function is to deliver material, not to diagnose a condition.
No
The device description explicitly details physical components like a cannula, plunger, dispenser, and end caps, indicating it is a hardware-based medical device for delivering bone graft material.
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 bone graft material to a surgical site. This is a therapeutic/surgical intervention, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a delivery system for a material. It doesn't analyze biological samples or provide diagnostic information.
- No mention of IVD activities: There is no mention of analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes.
The device is clearly intended for use during surgery to facilitate the placement of bone graft material.
N/A
Intended Use / Indications for Use
The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Allograft MIS Delivery System is a sterile, single-use, disposable graft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery system consists of: a cannula for containing and delivering the allograft material to the surgical site; a plunger to express the allograft material from the cannula; a dispenser to advance the plunger down the length of the cannula; and two end caps to retain the allograft material in the cannula prior to system assembly.
The cannula component is a 5 cc straight, open bore tube with a double threaded interface that mates with two end caps which are removed prior to cannula attachment to the dispenser. The dispenser is designed for single-hand, incremental delivery of graft materials and may be used to dispense multiple cannulas for a single patient.
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)
The following testing was performed on the subject device to demonstrate substantial equivalence:
- Biocompatibility
- Dimensional and fit verification
- Functional verification
- Mechanical extrusion
- Simulated use
- Package performance and stability
Testing was performed on samples that represented the finished device and all specified acceptance criteria were met.
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.
July 13, 2020
LifeNet Health Brittany Beasley Global Regulatory Affairs Program Manager 1864 Concert Drive Virginia Beach, Virginia 23453
Re: K201338
Trade/Device Name: Allograft MIS Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: May 19, 2020 Received: May 20, 2020
Dear Brittany Beasley:
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.
1
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 and Part 809); 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201338
Device Name Allograft MIS Delivery System
Indications for Use (Describe)
The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Allograft MIS Delivery System
| Submitter Information: | |
|---|---|
| Name: | LifeNet Health |
| Address: | 1864 Concert Drive |
| Virginia Beach, Virginia 23453 | |
| Contact: | Brittany Beasley, RAC |
| Global Regulatory Affairs Program Manager | |
| Phone: | (757) 609-4201 |
| Email: | brittany_beasley@lifenethealth.org |
| Date Prepared: | July 10, 2020 |
| Device Information: | |
| Trade Name: | Allograft MIS Delivery System |
| Common Name: | Graft Delivery Device |
| Regulation Name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Regulatory Class: | Class II |
| Product Code: | FMF |
| Proposed Panel: | General Hospital |
| Predicate Device: | |
| Name: | Graftgun Universal Graft Delivery System (K180937 |
| Manufacturer: | SurGenTec LLC |
Device Description:
The Allograft MIS Delivery System is a sterile, single-use, disposable graft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery system consists of: a cannula for containing and delivering the allograft material to the surgical site; a plunger to express the allograft material from the cannula; a dispenser to advance the plunger down the length of the cannula; and two end caps to retain the allograft material in the cannula prior to system assembly.
The cannula component is a 5 cc straight, open bore tube with a double threaded interface that mates with two end caps which are removed prior to cannula attachment to the dispenser. The dispenser is designed for single-hand, incremental delivery of graft materials and may be used to dispense multiple cannulas for a single patient.
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Image /page/4/Picture/1 description: The image is a logo for LifeNet Health. The logo features a blue and green circular icon with a stylized human figure in the center. To the right of the icon is the text "LifeNet Health" in blue and green. Below the text is the tagline "Saving Lives. Restoring Health. Giving Hope." in blue.
Indications for Use:
The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.
Comparison of Technological Characteristics to the Predicate:
| | | Graftgun Universal Graft Delivery
System
(predicate device) | Allograft MIS
Delivery System
(subject device) |
|-----------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Applicant | SurGenTec | LifeNet Health |
| | Regulation No. &
Name | 21 CFR 880.5860,
Piston Syringe | 21 CFR 880.5860,
Piston Syringe |
| | Procode | FMF | FMF |
| | 510(K) Number | K180937 | K201338 |
| | Labeling | Indications for use | The Graftgun Universal 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. |
| | Prescription /
OTC Use | Prescription Use | Prescription Use |
| | Type of Use | Single, Disposable | Single, Disposable |
| Design | Mechanism of
operation | Graft material expressed from graft
tube via a plunger, operated by a
ratchet-actuated handle. Material
expressed from graft tube directly to
graft site. | Graft material expressed from
cannula via a plunger, operated by a
ratchet-actuated handle. Material
expressed from graft cannula
directly to graft site. |
| | Patient-contact
materials | Graft tube - Medical grade
polypropylene
Loading Device/Syringe Tube -
Medical grade polycarbonate
Radiopaque ring marker - Medical
grade stainless steel - 316L, 316F,
304H, 304HC and ABS | Graft cannula - Medical grade
polypropylene |
| | Graft
Tube/Cannula | Option of having the 5cc graft tube
provided clean to a graft facility,
preloaded with graft, packaged,
sterilized and shipped to the surgical
facility prior to the surgical
procedure. | Cannula provided sterile to a graft
facility, preloaded with graft,
packaged, and shipped to the
surgical facility prior to the surgical
procedure. |
| | Radiopaque
marker | Yes | No |
| | Volume capacity | Up to 5 cc | Up to 5 cc |
| | Volume markings | Yes | No |
| | | Graftgun Universal Graft Delivery
System
(predicate device) | Allograft MIS
Delivery System
(subject device) |
| Sterility | Sterility Claim /
SAL | Sterile, SAL 1 x 10-6
(see Note 1) | Sterile, SAL 1 x 10-6
(see Note 2) |
| | Sterilization
Method | Gamma irradiation | Dispenser & Plunger:
Gamma irradiation
Cannula & End caps:
Ethylene Oxide |
| | | Note 1: Graft tubes are provided to a
registered graft facility. Their
sterilization process is validated as
per their internal accepted standards
prior to the prefilled tubes being
shipped. | Note 2: Cannulas and end caps are
provided to a registered graft
facility. Their manufacturing steps
conform to Current Good Tissue
Practice requirements under 21
CFR 1271, Subpart D. |
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Performance Data:
The following testing was performed on the subject device to demonstrate substantial equivalence:
- Biocompatibility
- 트 Dimensional and fit verification
- I Functional verification
- -Mechanical extrusion
- -Simulated use
- 트 Package performance and stability
Testing was performed on samples that represented the finished device and all specified acceptance criteria were met.
Conclusion:
The Allograft MIS Delivery System is substantially equivalent to the Graftgun dispensing unit of the Graftgun Universal Graft Delivery System in intended use, mechanism of operation, patientcontacting materials, and intent to supply the device to a registered graft facility prior to the surgical facility. The differences between the subject device and the predicate device are minor and do not impact the safety and effectiveness of the subject device as demonstrated by the provided performance testing.