(376 days)
Not Found
No
The description focuses on the mechanical safety features of a syringe and needle system, with no mention of AI or ML.
No
The device is a syringe for fluid aspiration and injection, not for treating a disease or condition.
No
The device is a syringe indicated for fluid aspiration and injection, not for diagnosing conditions.
No
The device description clearly outlines a physical syringe with a needle and an internal retraction mechanism, indicating it is a hardware device, not software-only.
Based on the provided text, the PowerPAK™ Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the aspiration and injection of fluids into the human body (subcutaneous, intradermal, intramuscular routes). This is a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The PowerPAK™ Syringe does not perform any such tests on samples outside the body.
- Device Description: The description focuses on the mechanical function of the syringe for aspiration and injection, and the safety features related to needle retraction. It does not mention any components or functions related to analyzing biological samples.
Therefore, the PowerPAK™ Syringe is a medical device used for administering or withdrawing substances from the body, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MEG, FMF, FMI
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult population patients
Intended User / Care Setting
medical professionals for pediatric and adult population patients for aspiration of fluids.
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)
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
- 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: The 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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
1
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
2
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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3
K220114 510(K) SUMMARY
Submitter Information:
| Company Name: | Vault Paragon Group, Inc. on behalf of L.O.M Laboratories |
|---|---|
| Company Address: | 189 3rd Street, A101 |
| Oakland, CA 94607 | |
| Company Phone: | 858-945-3651 |
| Contact Person: | Sari Luciano |
| Owner | |
| sluciano@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 | Classification
Regulation | 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.
4
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 | |||
|---|---|---|---|
| Comparison | |||
| Feature | Subject Device | Predicate Device | Same / Similar / |
| Different | |||
| Device Name | PowerPAKTM Syringe | BD IntegraTM Syringe | |
| Regulation Number | 21 CFR 880.5860 / 21 CFR | ||
| 880.5570 | 21 CFR 880.5860 | Similar | |
| (Comment 1) | |||
| Device | |||
| Classification | Class II | Class II | Same |
| Product Code | FMF, MEG, FMI | FMF, MEG | Similar |
| (Comment 2) | |||
| Indications for Use | The PowerPAKTM 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 PowerPAKTM Syringe is a
3mL syringe with a permanently
attached needle system. Routes
of Administration include
subcutaneous, intradermal and
intramuscular. Intravenous and
Intraperitoneal are not intended
uses of this device.
The needle system contains an
internal mechanism that retracts
the needle inside 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. | The BD Integra Syringe is used
for aspiration of fluids from vials
and ampoules and a variety of
fluid injections below the surface
of the skin. It is not intended to
be used for phlebotomy. The
Insulin syringe has scale lines in
insulin units and is used for
insulin injections. The tuberculin
syringe can be used for any of
the 3 types of common injections
(intra-dermal, intra-muscular,
subcutaneous).
The BD Integra TM 1ml Syringe
has a permanently attached
needle. The BD IntegraTM
contains a tool used to cut
through the hub and stopper
allowing the needle to become
retracted inside the plunger rod
of the syringe after use. After
activation the needle is fully
contained inside the syringe
guarding against accidental
needle sticks during normal
handling and disposal of the
used needle/syringe
combination. | Similar
(Comment 3) |
| Syringe Type | Plunger, anti-Stick with
Hypodermic Needle | Plunger, anti-Stick with
Hypodermic Needle | Same |
| Safety Features | Active Safety Feature, manually
activated by user | Active Safety Feature, manually
activated by user | Same |
| Tip Type | Tri-Beveled Tip | Tri-Beveled Tip | Same |
| Volume | 3 mL | 1mL and 3mL | Similar
(Comment 4) |
| Comparison
Feature | 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, 25G
1mL (G): 30-25 | Similar
(Comment 6) |
| Needle Tip
Configuration | 15 oC regular point | 15 oC regular point | Same |
| Nozzle Type | Needle Assembly & syringe not
separable | 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 ISO
7864 | Traditional Cover comply to ISO
7864 | 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 |
| Delivery
Accuracy/Capacity
Tolerance | Comply to ISO 7886-1 | Comply to ISO 7886-1 | Same |
| Hub/Needle Bond
Strength | Conform to ISO 7864 | Conform to ISO 7864 | Same |
| Re-use Prevention
Features | Conform to ISO 7886-4 ; and FDA
Guidance, Submission for
Medical Devicewith Sharps Injury
Prevention Features | Conform to ISO 7886-4 | Similar
(Comment 8) |
| Re-use Durability | Can't be re-used as required by
ISO 7886-4 | Can't be re-used as required by
ISO 7886-4 | Same |
| Primary Package
Barrier | Sterile Barrier of primary package
according to ISO 11607-1/2 | Sterile Barrier of primary package
according 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 Part
801 | Conforms to ISO 7886, ISO 7886-
1 & ISO 7886-4, and 21 CFR Part
801 | Same |
| Sterilization Level and
Method | 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 for
Retraction Mechanism | Venting | No Venting | Different
(Comment 11) |
5
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.
6
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.
7
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
8
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.