(376 days)
The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration of fluids. Phlebotomy is not an intended use of this device.
The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intraperitoneal are not intended uses of this device.
The needle system contains an internal mechanism that retracts the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidenticks during normal handling and disposal.
The PowerPAK™ syringe is single-use, non-reusable, sterile safety syringe containing a 22GA needle with a usable needle length of 1.80 inches and a syringe capacity of 3mL. The PowerPAK™ Syringe is indicated for general medical use by healthcare providers in the aspiration and injection of fluids via subcutaneous, intradermal, and intramuscular routes of administration. Phlebotomy and intravenous use are not an intended use of this device.
The PowerPAK™ syringe is a 3mL safety syringe with a permanently attached needle system containing an internal mechanism that retracts the needle inside the plunger rod of the syringe to prevent reuse of the syringe and accidental needle sticks during normal handling and disposal. Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates needle retraction. Propellant is the same medical grade propellant currently used in legally marketed dose inhalers.
The subject device is a single use, non-reusable, sterile safety syringe comprised of three main components including a Plunger, Syringe body, and Needle System.
I am sorry, but the provided text describes an FDA 510(k) clearance letter for a medical device called the "PowerPAK Syringe." This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing against various ISO standards and FDA guidance documents.
The document does not contain information about:
- Acceptance criteria and reported device performance in a table format for qualitative measures. The listed tests are primarily pass/fail against standards for physical properties, materials, and sterilization, not typical subjective performance metrics (like accuracy, precision, sensitivity, specificity, or image quality) that would require an acceptance criteria table.
- Sample size used for a "test set" in the context of an AI/ML study. The tests mentioned are for device performance, biocompatibility, and sterilization, where sample sizes are typically specified by the relevant ISO standards.
- Data provenance (country of origin, retrospective/prospective) related to AI/ML model training or testing.
- Number of experts used or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human-in-the-loop performance improvement.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML model.
- Sample size for a training set (AI/ML).
- How ground truth for a training set was established (AI/ML).
The document primarily focuses on the device's physical and functional characteristics, safety features (needle retraction), biocompatibility, and sterilization, and its comparison to a similar predicate device. It confirms that the device meets existing performance standards for syringes and sharps injury prevention.
Therefore, I cannot provide the requested information as it is not present in the given text.
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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vault Paragon Group, Inc. Sari Luciano Managing Partner 189 3rd Street A101 Oakland, California 94607
Re: K220114
Trade/Device Name: PowerPAKTM Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMI Dated: December 21, 2022 Received: December 22, 2022
Dear Sari Luciano:
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 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
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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.
Courtney Digitally signed by Date: 2023.01.25 Evans -S 18:00:01 -05'00'
For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K220114
Device Name PowerPAK Syringe
Indications for Use (Describe)
The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration of fluids. Phlebotomy is not an intended use of this device.
The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intraperitoneal are not intended uses of this device.
The needle system contains an internal mechanism that retracts the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidenticks during normal handling and disposal.
| 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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K220114 510(K) SUMMARY
Submitter Information:
| Company Name: | Vault Paragon Group, Inc. on behalf of L.O.M Laboratories |
|---|---|
| Company Address: | 189 3rd Street, A101Oakland, CA 94607 |
| Company Phone: | 858-945-3651 |
| Contact Person: | Sari LucianoOwnersluciano@vpgmed.com |
| Date: | January 23, 2023 |
| Device Information Information: | |
| Device Trade Name: | PowerPAK™ Syringe |
| Common Name: | Syringe, Antistick |
| Classification Name(s): | Piston Syringe, Antistick Syringe, Hypodermic Single Lumen Needle |
| Regulation: | 880.5860, 880.5570 |
| Device Class: | Class II |
| Product Code: | FMF, MEG, FMI |
| Advisory Panel: | General Hospital |
Predicate Device:
The Subject Device is substantially equivalent to the following device:
| Device Name | ClassificationRegulation | Product Code | 510(K)Number | Clearance Date |
|---|---|---|---|---|
| BD Integra Syringe | 880.5860 | FMF, MEG | K023752 | 2/7/2003 |
Device Description
The PowerPAK™ syringe is single-use, non-reusable, sterile safety syringe containing a 22GA needle with a usable needle length of 1.80 inches and a syringe capacity of 3mL. The PowerPAK™ Syringe is indicated for general medical use by healthcare providers in the aspiration and injection of fluids via subcutaneous, intradermal, and intramuscular routes of administration. Phlebotomy and intravenous use are not an intended use of this device.
The PowerPAK™ syringe is a 3mL safety syringe with a permanently attached needle system containing an internal mechanism that retracts the needle inside the plunger rod of the syringe to prevent reuse of the syringe and accidental needle sticks during normal handling and disposal. Activation of the syringe occurs when the forward plunger movement punctures the propellant gas cell inside the needle assembly and initiates needle retraction. Propellant is the same medical grade propellant currently used in legally marketed dose inhalers.
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The subject device is a single use, non-reusable, sterile safety syringe comprised of three main components including a Plunger, Syringe body, and Needle System.
Indications for Use
The PowerPAK™ Syringe is indicated for general medical use in healthcare facilities by medical professionals for pediatric and adult population patients for aspiration and injection of fluids. Phlebotomy is not an intended use of this device.
The PowerPAK™ Syringe is a 3mL syringe with a permanently attached needle system. Routes of Administration include subcutaneous, intradermal and intramuscular. Intraperitoneal are not intended uses of this device.
The needle system contains an internal mechanism that retracts the syringe after activation. Upon retraction, the needle is fully contained inside the syringe preventing reuse of the needle and accidental needlesticks during normal handling and disposal.
Comparison of Technological Characteristics:
| Table 5.1: Comparison of Subject Device and Predicate Device | |||
|---|---|---|---|
| ComparisonFeature | Subject Device | Predicate Device | Same / Similar /Different |
| Device Name | PowerPAKTM Syringe | BD IntegraTM Syringe | |
| Regulation Number | 21 CFR 880.5860 / 21 CFR880.5570 | 21 CFR 880.5860 | Similar(Comment 1) |
| DeviceClassification | Class II | Class II | Same |
| Product Code | FMF, MEG, FMI | FMF, MEG | Similar(Comment 2) |
| Indications for Use | The PowerPAKTM Syringe isindicated for general medical usein healthcare facilities by medicalprofessionals for pediatric andadult population patients foraspiration and injection of fluids.Phlebotomy is not an intendeduse of this device.The PowerPAKTM Syringe is a3mL syringe with a permanentlyattached needle system. Routesof Administration includesubcutaneous, intradermal andintramuscular. Intravenous andIntraperitoneal are not intendeduses of this device.The needle system contains aninternal mechanism that retractsthe needle inside the syringe afteractivation. Upon retraction, theneedle is fully contained insidethe syringe preventing reuse ofthe needle and accidentalneedlesticks during normalhandling and disposal. | The BD Integra Syringe is usedfor aspiration of fluids from vialsand ampoules and a variety offluid injections below the surfaceof the skin. It is not intended tobe used for phlebotomy. TheInsulin syringe has scale lines ininsulin units and is used forinsulin injections. The tuberculinsyringe can be used for any ofthe 3 types of common injections(intra-dermal, intra-muscular,subcutaneous).The BD Integra TM 1ml Syringehas a permanently attachedneedle. The BD IntegraTMcontains a tool used to cutthrough the hub and stopperallowing the needle to becomeretracted inside the plunger rodof the syringe after use. Afteractivation the needle is fullycontained inside the syringeguarding against accidentalneedle sticks during normalhandling and disposal of theused needle/syringecombination. | Similar(Comment 3) |
| Syringe Type | Plunger, anti-Stick withHypodermic Needle | Plunger, anti-Stick withHypodermic Needle | Same |
| Safety Features | Active Safety Feature, manuallyactivated by user | Active Safety Feature, manuallyactivated by user | Same |
| Tip Type | Tri-Beveled Tip | Tri-Beveled Tip | Same |
| Volume | 3 mL | 1mL and 3mL | Similar(Comment 4) |
| ComparisonFeature | Subject Device | Predicate Device | Same / Similar /Different |
| Needle Length | 1.80 inches (usable length) | 22G: 1.5 inches (usable length) | Similar(Comment 5) |
| Needle Gauge | 22 G | 3mL (G): 21, 22, 23, 25G1mL (G): 30-25 | Similar(Comment 6) |
| Needle TipConfiguration | 15 oC regular point | 15 oC regular point | Same |
| Nozzle Type | Needle Assembly & syringe notseparable | Needle hub Locking-fit; Needle& syringe not separable | Similar(Comment 7) |
| Barrel Marking Specs | Scales as required by ISO 7886-1 | Scales as required by ISO 7886-1 | Same |
| Gradations Legibility | Legible according to ISO 7886-1 | Legible according to ISO 7886-1 | Same |
| Needle Cover Color | Traditional Cover comply to ISO7864 | Traditional Cover comply to ISO7864 | Same |
| Lubricant Amount | Comply to ISO 7864 & ISO 7886-1 | Comply to ISO 7864 & ISO 7886-1 | Same |
| Barrel Transparency | Clear as required by ISO 7886-1 | Clear as required by ISO 7886-1 | Same |
| DeliveryAccuracy/CapacityTolerance | Comply to ISO 7886-1 | Comply to ISO 7886-1 | Same |
| Hub/Needle BondStrength | Conform to ISO 7864 | Conform to ISO 7864 | Same |
| Re-use PreventionFeatures | Conform to ISO 7886-4 ; and FDAGuidance, Submission forMedical Devicewith Sharps InjuryPrevention Features | Conform to ISO 7886-4 | Similar(Comment 8) |
| Re-use Durability | Can't be re-used as required byISO 7886-4 | Can't be re-used as required byISO 7886-4 | Same |
| Primary PackageBarrier | Sterile Barrier of primary packageaccording to ISO 11607-1/2 | Sterile Barrier of primary packageaccording to ISO 11607-1/2 | Same |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Same |
| Performance | Conforms to ISO 7864, ISO 7886-1 & ISO 7886-4 | Conforms to ISO 7864, ISO 7886-1& ISO 7886-4 | Same |
| Labeling | Conforms to ISO 7886, ISO 7886-1 & ISO 7886-4, and 21 CFR Part801 | Conforms to ISO 7886, ISO 7886-1 & ISO 7886-4, and 21 CFR Part801 | Same |
| Sterilization Level andMethod | Ethylene Oxide (SAL 10-6) | Ethylene Oxide (SAL 10-6);Gamma sterilization | Similar(Comment 9) |
| Shelf Life | 1Year | 5 Years | Different(Comment 10) |
| Retraction (Safety)Mechanism | Manual activation | Manual activation | Same |
| Venting Path forRetraction Mechanism | Venting | No Venting | Different(Comment 11) |
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Comment 1: Performance standards for both regulation numbers are are met by the subject device. Additional regulation number listed for subject device does not raise additional questions in safety and efficacy.
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Comment 2: Standards for predicate product codes (FMF, MEG) and additional product code (FMI) listed for subject device have been met and do not raise additional questions in safety and efficacy as evidenced by performance testing.
Comment 3: Intended Use of the subject device falls within the intended use of the predicate and does not raise additional questions of safety and efficacy.
Comment 4: The additional device configurations for the predicate does not raise additional questions of safety and efficacy for the subject device as evidenced by performance testing.
Comment 5: Variance in device specification does not raise additional questions of safety and efficacy as evidenced by performance testing.
Comment 6: Variance in the predicate device specification for the 1mL and a 3mL, does not raise additional questions of safety and efficacy for the 3mL subject device as evidenced by performance testing.
Comment 7: Variance in device specification does not raise additional questions of safety and efficacy as evidenced by performance testing.
Comment 8: Predicate 510(k) submission does not indicate utility of FDA Guidance document, Submission for Medical Device with Sharps Injury Prevention Features (Aug 9, 2005). Guidance was published after predicate device clearance on Feb 7, 2003. Conformance with the previously used ISO standards for the predicate device, in addition to FDA guidance documentation does not raise additional questions of safety or efficacy for the subject device.
Commet 9: The predicate and subject device both use EO (SAL 10°) for sterilization. The alternate method of sterilization used by the predicate does not raise additional questions of safety and efficacy for the subject device.
Comment 10: Variance in shelf life of the subject device does not raise additional questions of safety or efficacy as evidenced by aging and performance testing.
Comment 11: The predicate device operates on a spring mechanism for the energy source of retraction. The subject device uses propellant as the energy source for retraction. Both devices have the same performance requirements.
Propellant used for the retraction mechanism in the subject device is legally marketed in the United States and is used for dose inhalers (asthma sprays). The propellant does not raise additional questions of safety and efficacy.
Venting for the subject device is completed through multiple vents located on the back (posterior) end of the PowerPAK syringe. The septum located at the tip (anterior) of the needle system prevents propellant venting through the anterior of the syringe. Venting in the subject device does not raise additional questions of safety and efficacy.
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Non Clinical Performance Testing:
- Biocompatibility:
ISO 10993-1:2018 - Biological evaluation of medical devices - part 1: evaluation and testing within risk management
ISO 10993-5:2009 - Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 / ISO 10993-23: 2021 - Biological evaluation of medical devices - part 10: Tests for irritation and skin sensitization
ISO 10993-4:2010 - Biological evaluation of medical devices - part 4: Tests for ASTM Hemolysis
ISO 10993-11:2010 / USP 151 - Biological evaluation of medical devices - part 11: Tests for pyrogenicity
ISO 10993-11:2017 - Biological evaluation of medical devices - part 11: Tests for Toxicity
- Performance:
ISO 7886-1:2017- Leakage during aspiration
ISO 7886-1:2017 - Determination of Dead Space
ISO 7886-1:2017 - Leakage during compression
ISO 7886-1:2017 - Piston operating force
ISO 7886-1:2017(en) - Silicone quantity (lubricant)
ISO 7886-1:2017(en) - Limits for Extractable Metals
ISO 7864:2016 (en) - Needle fragmentation
ISO 7864:2016 (en) - Needle flow rate
ISO 7864:2016 (en) - Needle penetration & drag force
ISO 7864:2016 (en) - Needle bonding strength
ISO 23908:2011 - Needle Safety Mechanism
ISO 9626:2016 - Needle Stiffness
ISO 9626:2016 - Needle Resistance to breakage
ISO 9626:2016 - Needle Resistance to corrosion
ISO 7886-4:2018 - Re-use prevention feature
ISO 7886-1:2017(en) - Limits for Alkalinity/Acidity
ISO 7864: 2016 (en) - Limits for Extractable Metals
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ISO 7864-1:2016(en) - Limits for Alkalinity/Acidity
ISO 7864:2016 (en) - Needle Silicone quantity (lubricant)
ISO 7886-1:2017(en) - Graduated Tolerance Testing
USP 788 - Particulate Testing
FDA Guidance for Industry & FDA Staff Medical Devices with Sharps Injury Prevention Features (August 9, 2005): The rate of fluid flow simulating extremes of pressure (e.g., the maximum force applied to the piston).
- Transportation:
ASTM D4169-16:2016 - Standard Practice for Performance Testing of Shipping Containers and Systems
- Packaging:
ASTM F1886: 2016 - Visual Inspection
ASTM F2096:2011 - Bubble Emission
ASTM F88/F88M: 2015 - Seal Peel Strength
- Sterilization: ANSI/AAMISO
ANS/AAM ISO 11135-1:2014 Sterilization of healthcare products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7L Ethylene oxide residuals
ANSI/AAMISO 11737-1:2006 Sterilization of medical devices - microbial methods - Part 1: Determination of a population of microorganisms on products
ANSI/AAMISO 11737-2:2009 Sterilization of medical devices - microbial methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterility process
- Biosafety (Endotoxin):
ANSI / AAMI ST72
- Human Factor - Usability Study:
FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices (Dated: 2/3/2016)
FDA Guidance: Medical Devices with Sharps Injury Prevention Features (Dated: 8/9/2005)
Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use.
Conclusions Drawn from Nonclinical Evaluation:
The results of the evaluation demonstrate that the PowerPak™ Syringe is Substantially Equivalent to the predicate device as it pertains to the indications for use and device performance.
§ 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).