(153 days)
No
The device description and intended use clearly define a mechanical needle infusion set with no mention of AI or ML capabilities.
No.
The device is used to assist in the delivery of saline into a tissue expander, which is not considered a direct therapeutic action itself, but rather an accessory to a reconstructive procedure.
No
The device is described as a "needle infusion set component" used to deliver sterile saline for tissue expansion, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical components: needles, a needle hub, a luer adapter, and tubing. There is no mention of software.
Based on the provided information, the Unger Quad Injector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for assisting in the delivery of sterile saline into a surgically-placed tissue expander. This is a procedure performed in vivo (within the body) on a patient.
- Device Description: The device is described as a "needle infusion set component" comprised of needles, a hub, luer adapter, and tubing. These are components used for delivering substances into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Unger Quad Injector does not perform any such analysis of bodily specimens.
Therefore, the Unger Quad Injector is a medical device used for an in vivo procedure, not an IVD.
N/A
Intended Use / 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.
Product codes
LCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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
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.
Bench Tests conducted:
- Pre-clinical Investigational Evaluation of Tissue Expander Inter-operative Filling Device: Stradis Unger Quad Injector (Purpose: Compare performance of the B. Braun infusion set with the Unger Quad Injector as they perform as part of Tissue Expander Fill Kits)
- Quad Injector Flow Rate Comparison (Purpose: Compare performance of the B. Braun infusion set with the Unger Quad Injector as they perform as part of Tissue Expander Fill Kits)
- Unger Quad Injector Bioburden Test
- Unger Quad Injector Endotoxin Test
- Unger Quad Injector Bioburden Validation Test
- Shelf Life / Expiration Dating – Aging Testing (Purpose: Device Functionality and Packaging Integrity)
- ISO 7864 Hub Needle Bond Strength (Purpose: To Determine Hub Needle Bond Strength in conformance with ISO 7864)
- ISO 7864 and ISO 9626 (Purpose: Conformance with ISO 7864 and ISO 9626)
Key Results: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K853014, K121607, K102584, K150263, K961524, K923689, K955709, K945184, K950597
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
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.
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Date prepared: October 28, 2015
| Submitter / Contact Person | H. Carl Jenkins
The Wood Burditt Group
10 E. Scranton Ave, Suite 201
Lake Bluff, IL 60044
(ph) 847-234-7500 x 205
(fax) 847-578-0728
(email) hcjenkins@woodburditt.com |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant / Specifications
Developer / Packager | Stradis Healthcare
805 Marathon Pkwy, Ste 100
Lawrenceville, GA 30046
(ph) 847-596-7716
FDA Establishment Registration Number: 1055754
FEI Number: 1000111025 |
| Manufacturer | Surgistar, Inc
2310 La Mirada Dr |
| 2310 La Mirada Dr.
Vista, CA 92081
(ph) 760-598-2480 | |
| FDA Establishment Registration Number: 2028661
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 |
4
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
Substantial Equivalence |
|---------------------------------------------------------------------------------------------|-------------------------------|----------|--------------------------------------------------------------------------|
| McGhan Tissue
Expander Fill System
(Predicate Device) | McGhan | K870754 | Intended Use / Indications
for Use / Technological
Characteristics |
| McGhan Tissue
Expander Fill Kit (the
needles for which are
also marketed as the B. | McGhan | K853014 | Intended Use / Indications
for Use; Needle Gauge; |
| Braun Infusion Set –
Universal Fill Kit Component
(Reference Device) | | | Labeling / Technological
Characteristics |
| Terumo Needle
(Reference Device) | Terumo | K121607 | Needle Length; Device
Color |
| IMC Hypodermic
Needle
(Reference Device) | IMC | K102584 | Tip Configuration |
| K-Pack II Needle
(Reference Device) | K-Pack | K150263 | Hub / Needle Bond
Strength |
| Sterilab Needles
(Reference Device) | Sterilab | K961524 | Biocompatibility;
Materials |
| Surgistar Blades
(Reference Device) | Surgistar | K923689 | Biocompatibility;
Materials |
| Winged Infusion Set
(Reference Device) | Distronic Sterile
Products | K955709 | Biocompatibility;
Materials |
| Intravascular
Administration Set
(Reference Device) | Distronic Sterile
Products | K945184 | Biocompatibility;
Materials |
| Core-Resistant Huber
Infusion Set
(Reference Device) | Distronic Sterile
Products | K950597 | Biocompatibility;
Materials |
5
6
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 | |
| a tissue expander fill kit for breast | ||
| tissue expanders; lumen needles at | ||
| one end of the device; female | ||
| connector (hub) designed to mate | ||
| with a male connector (nozzle) of a | ||
| syringe at the other end of the | ||
| device. | Predicate Device: | |
| McGhan Tissue Expander Fill | ||
| System (K870754): "A 21G butterfly | ||
| needle for filling the injection | ||
| reservoir of the tissue expander" | ||
| (p. 7, Attachment 12A). | ||
| Reference Device: | ||
| McGhan Tissue Expander Fill Kit | ||
| (K853014): Needle infusion set | ||
| component "for use with Allergan | ||
| Fill Kit" (lumen needles at one end | ||
| of the device; hub designed to | ||
| mate with nozzle of a syringe at the | ||
| other end of the device). | ||
| Gauge | 21G | Predicate Device: |
| McGhan Tissue Expander Fill | ||
| System (K870754): "A 21G butterfly | ||
| needle for filling the injection | ||
| reservoir of the tissue expander" | ||
| Reference Device: | ||
| McGhan Tissue Expander Fill Kit | ||
| (marketed as the B. Braun Infusion | ||
| Set - Universal Fill Kit Component) | ||
| (K853014): "21 Ga. Needle Infusion | ||
| Set". | ||
| Needle Length | 38mm | Reference Device: |
| Terumo Needle (K121607): 21G | ||
| Needle Length: 38mm | ||
| Tip Configuration | Per ISO 7864 | Reference Device: |
| IMC Hypodermic Needle | ||
| (K102584): Per ISO 7864 | ||
| Color | Hub color coded following ISO |
- 21G Needle Color: Green | Reference Device:
Terumo Needle (K121607): 21G
Needle Color: Green |
| Hub / Needle Bond Strength | 21G – Minimum 44N
Per ISO 7864 | Reference Device:
K-Pack II Needle (K150263): 21G –
Minimum 44N |
| Materials | Needle: 304 Stainless Steel
Hypodermic Tubing | Same Needle Material (304
Stainless Steel Hypodermic Tubing)
used in:
- K853014 - B. Braun Infusion
Set (Predicate Device) - K955709 – Winged and
Subcutaneous Infusion Set
(Reference Device) - K961524 – Sterilab Sterile
Disposable Instruments –
Needles - Identical 304
Stainless Steel Hypodermic
Tubing. (Reference Device) |
| | | |
| Needle Cover/Sheath: 640I LDPE
(Low Density Polyethylene) | Same Cover/Sheath Material used
in: - K945184 - Intravascular
Administration Set (Reference
Device) - K950597 – Core-Resistant
Huber Infusion Set (Reference
Device) | |
| ABS Cap and Base: ABS Plastic | Same ABS plastic used in: - K923689 – Surgistar Blades –
Handles made of same ABS
Plastic (Reference Device) | |
| Tubing: Non-DEHP PVC | Same material used for tubing in: - K955709 Winged &
Subcutaneous Infusion Set
(Reference Device) - K945184 - Intravascular
Administration Set (Reference
Device) | |
| Luer Lock: White Polypropylene | Same material used in luer lock in: - K961524 – Sterilab Needles
with Polypropylene Hub
(Reference Device) | |
| Chevron Pouch – Mylar/Tyvek | Same Mylar/Tyvek pouches in: - K955709 Winged &
Subcutaneous Infusion Set
(Reference Device) | |
7
8
9
Component materials and specifications are presented in the table below:
| Description | Material | Dimensions | Additional Specs. |
|---|---|---|---|
| 21G Hypodermic | |||
| Needle | 304 Stainless | ||
| Hypodermic | |||
| Tubing | 2.087" X .0323" OD X | ||
| .0233" ID | Tri-Facet Grind Bevel | ||
| Needle Cover | |||
| Sheath | 640I LDPE | 2.5" X .506" OD X | |
| .372" ID | Natural Color | ||
| ABS Cap and Base | ABS Plastic | 1" X .394" OD X .125" | |
| ID | ISO 6009 -- 21G Green | ||
| Tubing | Non-DEHP PVC | 12" X .184" OD X | |
| .125" ID | Clear, 70 Durometer | ||
| Luer Lock | White | ||
| Polypropylene | 1" X .234" OD Barb X | ||
| .117" ID | White Plastic | ||
| Chevron Pouch | 48GA PET/.002 | ||
| 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.
10
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 | |
| Tissue Expander Inter-operative Filling | |
| Device: Stradis Unger Quad Injector | Compare performance of the B. Braun infusion |
| set with the Unger Quad Injector as they perform | |
| as part of Tissue Expander Fill Kits | |
| Quad Injector Flow Rate Comparison | Compare performance of the B. Braun infusion |
| set with the Unger Quad Injector as they perform | |
| 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 | |
| Test | Bioburden Validation Test |
| Shelf Life / Expiration Dating – Aging | |
| Testing | Device Functionality and Packaging Integrity |
| ISO 7864 Hub Needle Bond Strength | To Determine Hub Needle Bond Strength in |
| conformance with ISO 7864 | |
| ISO 7864 and ISO 9626 | Conformance with ISO 7864 and ISO 9626 |
11
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.