Unger Quad Injector
Device Facts
| Record ID | K161483 |
|---|---|
| Device Name | Unger Quad Injector |
| Applicant | Stradis Healthcare |
| Product Code | LCJ · SU |
| Decision Date | Oct 31, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Therapeutic |
Indications for Use
The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21-gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.
Device Story
Unger Quad Injector is a needle infusion set component for breast tissue expander fill kits. Device consists of four 21-gauge hypodermic lumen needles connected to a needle hub, luer adapter, and tubing. Used by clinicians in clinical settings to deliver sterile saline into sub-dermal tissue expanders during breast augmentation procedures. Clinician attaches syringe to luer hub to infuse saline through needles into expander reservoir. Device facilitates controlled saline delivery to expand tissue. Benefits include improved infusion process for breast tissue expansion.
Clinical Evidence
No clinical tests were conducted. Substantial equivalence is supported by bench testing, including flow rate comparison, bioburden and endotoxin testing, shelf-life/aging testing, and mechanical testing (hub/needle bond strength per ISO 7864).
Technological Characteristics
Needle infusion set with four 21G 304 stainless steel needles, non-DEHP PVC tubing, and polypropylene luer lock. Materials include 640I LDPE sheath and ABS plastic cap/base. Hub/needle bond strength minimum 44N per ISO 7864. EO sterilized per ANSI/AAMI/ISO 11135. Dimensions: 38mm needle length, 12-inch tubing. Color-coded per ISO 6009 (Green).
Indications for Use
Indicated for clinicians to deliver sterile saline into surgically-placed, sub-dermal, temporary, removable breast tissue expanders designed for 21-gauge needle filling.
Predicate Devices
Reference Devices
- B. Braun Infusion Set – Universal Fill Kit Component
- Terumo Needle (K121607)
- IMC Hypodermic Needle (K102584)
- K-Pack II Needle (K150263)
- Sterilab Needles (K961524)
- Surgistar Blades (K923689)
- Winged Infusion Set (K955709)
- Intravascular Administration Set (K945184)
- Core-Resistant Huber Infusion Set (K950597)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
Stradis Healthcare % Mr. Carl H. Jenkins The Wood Burditt Group 10 East Scranton Avenue, Suite 201 Lake Bluff, Illinois 60044
Re: K161483
Trade/Device Name: Unger Quad Injector Regulatory Class: Unclassified Product Code: LCJ Dated: September 8, 2016 Received: September 12, 2016
Dear Mr. Jenkins:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
# David-Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K161483
Device Name Unger Quad Injector
Indications for Use (Describe)
The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21-gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.
Type of Use (Select one or both, as applicable)
| <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# 510(k) Summary
Date prepared: October 28, 2015
| Submitter / Contact Person | H. Carl Jenkins<br>The Wood Burditt Group<br>10 E. Scranton Ave, Suite 201<br>Lake Bluff, IL 60044<br>(ph) 847-234-7500 x 205<br>(fax) 847-578-0728<br>(email) hcjenkins@woodburditt.com |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant / Specifications<br>Developer / Packager | Stradis Healthcare<br>805 Marathon Pkwy, Ste 100<br>Lawrenceville, GA 30046<br>(ph) 847-596-7716<br>FDA Establishment Registration Number: 1055754<br>FEI Number: 1000111025 |
| Manufacturer | Surgistar, Inc<br>2310 La Mirada Dr |
| 2310 La Mirada Dr.<br>Vista, CA 92081<br>(ph) 760-598-2480 | |
| FDA Establishment Registration Number: 2028661<br>FEI Number: 3005765014 | |
| Device | |
|---------------------|--------------------------------------------------------|
| Trade Name | Unger Quad Injector |
| Proprietary Name | Unger Quad Injector |
| Common Name | Needle Infusion Set - Breast Tissue Expander Accessory |
| Classification Name | Breast Tissue Expander - Accessory |
| Advisory Panel | General and Plastic Surgery Advisory Panel |
| Regulation | Unclassified |
| Product Code | LCJ |
| Classification | Unclassified |
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### Reason for 510(k) Submission
The applicant device is a new device.
#### Device Description
The Unger Quad Injector is a 'needle infusion set' component to a breast tissue expander fill kit. The device is comprised of four 21 gauge hypodermic lumen needles, which are connected to a needle hub, a luer adapter and tubing.
The Unger Quad Injector was developed with the intent to improve the infusion of saline solution into a tissue expander used in breast augmentation procedures.
#### Indications for Use:
The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.
#### Predicate and Reference Device Summary Table
Based on the comparison of the device features, materials, intended use and performance the Unger Quad Injector was shown to be substantially equivalent to the lawfully marketed predicate devices indicated in the table below.
| Device | Applicant | 510(k) # | Featured Element(s) of<br>Substantial Equivalence |
|---------------------------------------------------------------------------------------------|-------------------------------|----------|--------------------------------------------------------------------------|
| McGhan Tissue<br>Expander Fill System<br>(Predicate Device) | McGhan | K870754 | Intended Use / Indications<br>for Use / Technological<br>Characteristics |
| McGhan Tissue<br>Expander Fill Kit (the<br>needles for which are<br>also marketed as the B. | McGhan | K853014 | Intended Use / Indications<br>for Use; Needle Gauge; |
| Braun Infusion Set –<br>Universal Fill Kit Component<br>(Reference Device) | | | Labeling / Technological<br>Characteristics |
| Terumo Needle<br>(Reference Device) | Terumo | K121607 | Needle Length; Device<br>Color |
| IMC Hypodermic<br>Needle<br>(Reference Device) | IMC | K102584 | Tip Configuration |
| K-Pack II Needle<br>(Reference Device) | K-Pack | K150263 | Hub / Needle Bond<br>Strength |
| Sterilab Needles<br>(Reference Device) | Sterilab | K961524 | Biocompatibility;<br>Materials |
| Surgistar Blades<br>(Reference Device) | Surgistar | K923689 | Biocompatibility;<br>Materials |
| Winged Infusion Set<br>(Reference Device) | Distronic Sterile<br>Products | K955709 | Biocompatibility;<br>Materials |
| Intravascular<br>Administration Set<br>(Reference Device) | Distronic Sterile<br>Products | K945184 | Biocompatibility;<br>Materials |
| Core-Resistant Huber<br>Infusion Set<br>(Reference Device) | Distronic Sterile<br>Products | K950597 | Biocompatibility;<br>Materials |
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## Technological characteristics and comparison
The Unger Quad Injector is substantially equivalent to the McGhan Tissue Expander Fill System (K870754) in terms of technological characteristics and indications for use. The predicate device is comprised, in part, of a 21 G butterfly needle for filling the injection reservoir of the tissue expander.
In addition, several other Reference Devices demonstrate the safety and efficacy of the Unger Quad Injector in terms of supporting scientific methodology and/or standard reference values.
# Summary of the Technological Characteristics of Subject Device and Predicate/Reference Devices (21 CFR 807.92(a)(6))
| Feature | Unger Quad Injector | Predicate and Reference Devices |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Needle infusion set component of<br>a tissue expander fill kit for breast<br>tissue expanders; lumen needles at<br>one end of the device; female<br>connector (hub) designed to mate<br>with a male connector (nozzle) of a<br>syringe at the other end of the<br>device. | Predicate Device:<br>McGhan Tissue Expander Fill<br>System (K870754): "A 21G butterfly<br>needle for filling the injection<br>reservoir of the tissue expander"<br>(p. 7, Attachment 12A).<br>Reference Device:<br>McGhan Tissue Expander Fill Kit<br>(K853014): Needle infusion set<br>component "for use with Allergan<br>Fill Kit" (lumen needles at one end<br>of the device; hub designed to<br>mate with nozzle of a syringe at the<br>other end of the device). |
| Gauge | 21G | Predicate Device:<br>McGhan Tissue Expander Fill<br>System (K870754): "A 21G butterfly<br>needle for filling the injection<br>reservoir of the tissue expander" |
| | | Reference Device: |
| | | McGhan Tissue Expander Fill Kit<br>(marketed as the B. Braun Infusion<br>Set - Universal Fill Kit Component)<br>(K853014): "21 Ga. Needle Infusion<br>Set". |
| Needle Length | 38mm | Reference Device:<br>Terumo Needle (K121607): 21G<br>Needle Length: 38mm |
| Tip Configuration | Per ISO 7864 | Reference Device:<br>IMC Hypodermic Needle<br>(K102584): Per ISO 7864 |
| Color | Hub color coded following ISO<br>6009. 21G Needle Color: Green | Reference Device:<br>Terumo Needle (K121607): 21G<br>Needle Color: Green |
| Hub / Needle Bond Strength | 21G – Minimum 44N<br>Per ISO 7864 | Reference Device:<br>K-Pack II Needle (K150263): 21G –<br>Minimum 44N |
| Materials | Needle: 304 Stainless Steel<br>Hypodermic Tubing | Same Needle Material (304<br>Stainless Steel Hypodermic Tubing)<br>used in:<br>- K853014 - B. Braun Infusion<br>Set (Predicate Device)<br>- K955709 – Winged and<br>Subcutaneous Infusion Set<br>(Reference Device)<br>- K961524 – Sterilab Sterile<br>Disposable Instruments –<br>Needles - Identical 304<br>Stainless Steel Hypodermic<br>Tubing. (Reference Device) |
| | | |
| Needle Cover/Sheath: 640I LDPE<br>(Low Density Polyethylene) | Same Cover/Sheath Material used<br>in:<br>- K945184 - Intravascular<br>Administration Set (Reference<br>Device)<br>- K950597 – Core-Resistant<br>Huber Infusion Set (Reference<br>Device) | |
| ABS Cap and Base: ABS Plastic | Same ABS plastic used in:<br>- K923689 – Surgistar Blades –<br>Handles made of same ABS<br>Plastic (Reference Device) | |
| Tubing: Non-DEHP PVC | Same material used for tubing in:<br>- K955709 Winged &<br>Subcutaneous Infusion Set<br>(Reference Device)<br>- K945184 - Intravascular<br>Administration Set (Reference<br>Device) | |
| Luer Lock: White Polypropylene | Same material used in luer lock in:<br>- K961524 – Sterilab Needles<br>with Polypropylene Hub<br>(Reference Device) | |
| Chevron Pouch – Mylar/Tyvek | Same Mylar/Tyvek pouches in:<br>- K955709 Winged &<br>Subcutaneous Infusion Set<br>(Reference Device) | |
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Component materials and specifications are presented in the table below:
| Description | Material | Dimensions | Additional Specs. |
|--------------------------|---------------------------------------|-----------------------------------|-----------------------|
| 21G Hypodermic<br>Needle | 304 Stainless<br>Hypodermic<br>Tubing | 2.087" X .0323" OD X<br>.0233" ID | Tri-Facet Grind Bevel |
| Needle Cover<br>Sheath | 640I LDPE | 2.5" X .506" OD X<br>.372" ID | Natural Color |
| ABS Cap and Base | ABS Plastic | 1" X .394" OD X .125"<br>ID | ISO 6009 -- 21G Green |
| Tubing | Non-DEHP PVC | 12" X .184" OD X<br>.125" ID | Clear, 70 Durometer |
| Luer Lock | White<br>Polypropylene | 1" X .234" OD Barb X<br>.117" ID | White Plastic |
| Chevron Pouch | 48GA PET/.002<br>LDPE | 7.75" X 3.75" | Clear/White |
The Hub/Needle Bond Strength is: Minimum 44N, Per ISO 7864.
# Clinical test:
No clinical tests were conducted in support of this 510(k) submission.
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# Non Clinical Tests performed:
Bench testing related to performance, safety, effectiveness and specifications of the proposed device was conducted in order to verify the equivalence of performances with the predicate devices.
The following bench testing was conducted on the Unger Quad Injector in support of this 510(k) submission:
| Bench Test | Purpose |
|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Pre-clinical Investigational Evaluation of<br>Tissue Expander Inter-operative Filling<br>Device: Stradis Unger Quad Injector | Compare performance of the B. Braun infusion<br>set with the Unger Quad Injector as they perform<br>as part of Tissue Expander Fill Kits |
| Quad Injector Flow Rate Comparison | Compare performance of the B. Braun infusion<br>set with the Unger Quad Injector as they perform<br>as part of Tissue Expander Fill Kits |
| Unger Quad Injector Bioburden Test | Bioburden Test |
| Unger Quad Injector Endotoxin Test | Endotoxin Test |
| Unger Quad Injector Bioburden Validation<br>Test | Bioburden Validation Test |
| Shelf Life / Expiration Dating – Aging<br>Testing | Device Functionality and Packaging Integrity |
| ISO 7864 Hub Needle Bond Strength | To Determine Hub Needle Bond Strength in<br>conformance with ISO 7864 |
| ISO 7864 and ISO 9626 | Conformance with ISO 7864 and ISO 9626 |
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The data from the performance testing supports a finding of substantial equivalence because the data demonstrates that the Unger Quad Injector is safely and effectively indicated for use as the 'needle infusion set' component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21 gauge needles. Testing results demonstrate the filling, sealing capability and leakage prevention as compared to lawfully marketed predicate devices. Performance testing results also demonstrate safety and efficacy in terms of biocompatibility, sterilization, shelf life, and general device performance.
#### Sterilization:
Product is EO sterilized. Sterilization validation is in accordance with ANSI/AAMI/ISO 11135-2014, ISO 11135-1 and 11135-2.
The shelf life of the product will be established in accordance with appropriate and valid aging testing results.
#### Biocompatibility:
The Unger Quad Injector components are made with materials identical to equivalent components in other 510(k) cleared devices.
#### Conclusion
The applicant device is substantially equivalent in its intended use, technology / principal of operation, materials, and performance to the predicate devices identified in this 510(k) submission. There is no significant difference that raises any issues of safety or effectiveness.
