(153 days)
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.
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.
This document is a 510(k) premarket notification for the Unger Quad Injector, indicating it is a device intended for assisting in the delivery of sterile saline into breast tissue expanders. However, the provided text does not contain acceptance criteria or a study that evaluates the device against specific performance metrics for the purpose of demonstrating clinical accuracy or diagnostic performance, which is typically found in documentation for diagnostic or AI-enabled devices.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and non-clinical bench testing. The "acceptance criteria" discussed here are primarily related to conforming to established standards and matching the performance of predicate devices in specific non-clinical tests.
Here's a breakdown of the information that can be extracted or inferred from the provided text, adjusted to the context of this device:
Acceptance Criteria and Device Performance (Non-Clinical Bench Testing)
Since this is a non-AI, non-diagnostic device, the "acceptance criteria" are related to manufacturing standards, material properties, and functional performance compared to predicate devices, rather than accuracy metrics like sensitivity or specificity.
| Acceptance Criteria (Standard / Comparator) | Reported Device Performance (Unger Quad Injector) |
|---|---|
| Hub / Needle Bond Strength: Minimum 44N (Per ISO 7864) | Meets Criteria: 21G – Minimum 44N (Per ISO 7864) |
| Tip Configuration: Per ISO 7864 | Meets Criteria: Per ISO 7864 |
| Needle Color: Green (for 21G) (Following ISO 6009) | Meets Criteria: 21G Needle Color: Green |
| Flow Rate Performance: Comparable to B. Braun infusion set | Demonstrated Comparability: Flow rate comparison study conducted. (Specific results not detailed) |
| Material Biocompatibility: Identical to equivalent components in 510(k) cleared devices | Demonstrated Comparability: Materials are identical or comparable to predicate/reference devices. |
| Sterilization: In accordance with ANSI/AAMI/ISO 11135-2014, ISO 11135-1 & -2 | Validated: Product is EO sterilized, validation in accordance with standards. |
| Shelf Life/Expiration Dating: Established through appropriate aging testing | Under Establishment/Validated: Aging testing conducted; shelf life will be established. |
| Bioburden/Endotoxin: Pass specific tests | Passed: Bioburden Test, Endotoxin Test, Bioburden Validation Test conducted. |
| Filling, Sealing, Leakage Prevention: Comparable to predicate devices | Demonstrated Comparability: Testing results demonstrate capability. (Specific results not detailed) |
| Conformance: ISO 7864 and ISO 9626 | Demonstrated Conformance: Bench testing confirmed conformance. |
1. A table of acceptance criteria and the reported device performance:
See table above. The "reported device performance" indicates whether the device met the stated standard or showed comparability to the predicate/reference device, as described in the "Non Clinical Tests performed" section and the "Summary of the Technological Characteristics" table.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for each non-clinical bench test. The studies were non-clinical bench tests, not involving human subjects or real-world data provenance in the sense of patient data. The tests were conducted to verify equivalence.
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 is not applicable as this device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The evaluation is based on engineering and material standards and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests are bench tests against established standards or direct comparisons, not requiring expert adjudication.
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:
Not applicable. This device is not an AI-enabled diagnostic or assistance tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device does not involve an algorithm. The "standalone" performance here refers to the device's functional characteristics in isolation, which were assessed through the bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device is defined by:
- Established Industry Standards: Such as ISO 7864, ISO 9626, ISO 6009, ANSI/AAMI/ISO 11135.
- Performance of Legally Marketed Predicate Devices: The McGhan Tissue Expander Fill System (K870754) and other reference devices served as comparators for technological characteristics, materials, and functional performance.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
Summary of the Study:
The document describes a series of non-clinical bench tests rather than a clinical study. These tests were performed to demonstrate that the Unger Quad Injector is substantially equivalent to legally marketed predicate devices, primarily the McGhan Tissue Expander Fill System (K870754).
The specific non-clinical tests conducted include:
- Pre-clinical Investigational Evaluation of Tissue Expander Inter-operative Filling Device
- Quad Injector Flow Rate Comparison
- Unger Quad Injector Bioburden Test
- Unger Quad Injector Endotoxin Test
- Unger Quad Injector Bioburden Validation Test
- Shelf Life / Expiration Dating – Aging Testing
- ISO 7864 Hub Needle Bond Strength
- ISO 7864 and ISO 9626 Conformance
Purpose of the Studies: The main purpose was to verify the equivalence of the Unger Quad Injector's performance, safety, and specifications with the predicate devices, and to ensure conformance with relevant ISO standards.
Conclusion from the Studies: The data from these tests "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... 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."
No clinical tests were conducted. The device's safety and effectiveness were established through comparison of its technological characteristics and performance in bench tests to those of existing, legally marketed devices.
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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.
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date prepared: October 28, 2015
| Submitter / Contact Person | H. Carl JenkinsThe Wood Burditt Group10 E. Scranton Ave, Suite 201Lake Bluff, IL 60044(ph) 847-234-7500 x 205(fax) 847-578-0728(email) hcjenkins@woodburditt.com |
|---|---|
| Applicant / SpecificationsDeveloper / Packager | Stradis Healthcare805 Marathon Pkwy, Ste 100Lawrenceville, GA 30046(ph) 847-596-7716FDA Establishment Registration Number: 1055754FEI Number: 1000111025 |
| Manufacturer | Surgistar, Inc2310 La Mirada Dr |
| 2310 La Mirada Dr.Vista, CA 92081(ph) 760-598-2480 | |
| FDA Establishment Registration Number: 2028661FEI 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) ofSubstantial Equivalence |
|---|---|---|---|
| McGhan TissueExpander Fill System(Predicate Device) | McGhan | K870754 | Intended Use / Indicationsfor Use / TechnologicalCharacteristics |
| McGhan TissueExpander Fill Kit (theneedles for which arealso marketed as the B. | McGhan | K853014 | Intended Use / Indicationsfor Use; Needle Gauge; |
| Braun Infusion Set –Universal Fill Kit Component(Reference Device) | Labeling / TechnologicalCharacteristics | ||
| Terumo Needle(Reference Device) | Terumo | K121607 | Needle Length; DeviceColor |
| IMC HypodermicNeedle(Reference Device) | IMC | K102584 | Tip Configuration |
| K-Pack II Needle(Reference Device) | K-Pack | K150263 | Hub / Needle BondStrength |
| Sterilab Needles(Reference Device) | Sterilab | K961524 | Biocompatibility;Materials |
| Surgistar Blades(Reference Device) | Surgistar | K923689 | Biocompatibility;Materials |
| Winged Infusion Set(Reference Device) | Distronic SterileProducts | K955709 | Biocompatibility;Materials |
| IntravascularAdministration Set(Reference Device) | Distronic SterileProducts | K945184 | Biocompatibility;Materials |
| Core-Resistant HuberInfusion Set(Reference Device) | Distronic SterileProducts | K950597 | Biocompatibility;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 ofa tissue expander fill kit for breasttissue expanders; lumen needles atone end of the device; femaleconnector (hub) designed to matewith a male connector (nozzle) of asyringe at the other end of thedevice. | Predicate Device:McGhan Tissue Expander FillSystem (K870754): "A 21G butterflyneedle for filling the injectionreservoir of the tissue expander"(p. 7, Attachment 12A).Reference Device:McGhan Tissue Expander Fill Kit(K853014): Needle infusion setcomponent "for use with AllerganFill Kit" (lumen needles at one endof the device; hub designed tomate with nozzle of a syringe at theother end of the device). |
| Gauge | 21G | Predicate Device:McGhan Tissue Expander FillSystem (K870754): "A 21G butterflyneedle for filling the injectionreservoir of the tissue expander" |
| Reference Device: | ||
| McGhan Tissue Expander Fill Kit(marketed as the B. Braun InfusionSet - Universal Fill Kit Component)(K853014): "21 Ga. Needle InfusionSet". | ||
| Needle Length | 38mm | Reference Device:Terumo Needle (K121607): 21GNeedle Length: 38mm |
| Tip Configuration | Per ISO 7864 | Reference Device:IMC Hypodermic Needle(K102584): Per ISO 7864 |
| Color | Hub color coded following ISO6009. 21G Needle Color: Green | Reference Device:Terumo Needle (K121607): 21GNeedle Color: Green |
| Hub / Needle Bond Strength | 21G – Minimum 44NPer ISO 7864 | Reference Device:K-Pack II Needle (K150263): 21G –Minimum 44N |
| Materials | Needle: 304 Stainless SteelHypodermic Tubing | Same Needle Material (304Stainless Steel Hypodermic Tubing)used in:- K853014 - B. Braun InfusionSet (Predicate Device)- K955709 – Winged andSubcutaneous Infusion Set(Reference Device)- K961524 – Sterilab SterileDisposable Instruments –Needles - Identical 304Stainless Steel HypodermicTubing. (Reference Device) |
| Needle Cover/Sheath: 640I LDPE(Low Density Polyethylene) | Same Cover/Sheath Material usedin:- K945184 - IntravascularAdministration Set (ReferenceDevice)- K950597 – Core-ResistantHuber Infusion Set (ReferenceDevice) | |
| ABS Cap and Base: ABS Plastic | Same ABS plastic used in:- K923689 – Surgistar Blades –Handles made of same ABSPlastic (Reference Device) | |
| Tubing: Non-DEHP PVC | Same material used for tubing in:- K955709 Winged &Subcutaneous Infusion Set(Reference Device)- K945184 - IntravascularAdministration Set (ReferenceDevice) | |
| Luer Lock: White Polypropylene | Same material used in luer lock in:- K961524 – Sterilab Needleswith Polypropylene Hub(Reference Device) | |
| Chevron Pouch – Mylar/Tyvek | Same Mylar/Tyvek pouches in:- K955709 Winged &Subcutaneous Infusion Set(Reference Device) |
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Component materials and specifications are presented in the table below:
| Description | Material | Dimensions | Additional Specs. |
|---|---|---|---|
| 21G HypodermicNeedle | 304 StainlessHypodermicTubing | 2.087" X .0323" OD X.0233" ID | Tri-Facet Grind Bevel |
| Needle CoverSheath | 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 | WhitePolypropylene | 1" X .234" OD Barb X.117" ID | White Plastic |
| Chevron Pouch | 48GA PET/.002LDPE | 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 ofTissue Expander Inter-operative FillingDevice: Stradis Unger Quad Injector | Compare performance of the B. Braun infusionset with the Unger Quad Injector as they performas part of Tissue Expander Fill Kits |
| Quad Injector Flow Rate Comparison | Compare performance of the B. Braun infusionset with the Unger Quad Injector as they performas part of Tissue Expander Fill Kits |
| Unger Quad Injector Bioburden Test | Bioburden Test |
| Unger Quad Injector Endotoxin Test | Endotoxin Test |
| Unger Quad Injector Bioburden ValidationTest | Bioburden Validation Test |
| Shelf Life / Expiration Dating – AgingTesting | Device Functionality and Packaging Integrity |
| ISO 7864 Hub Needle Bond Strength | To Determine Hub Needle Bond Strength inconformance 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.
N/A