(129 days)
The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery.
The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.
The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid.
The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision.
The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification.
The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device.
The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2).
The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use.
Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.
The provided document is a 510(k) premarket notification for the Streamline® Viscoelastic Injector. It details the device's technical characteristics, intended use, and provides a comparison to a predicate device. It also lists performance testing conducted to demonstrate conformance to design specifications and applicable standards.
However, the document does not contain specific acceptance criteria values or detailed results of a study that directly proves the device meets those criteria in a quantitative sense as typically presented with metrics like sensitivity, specificity, or F1-score. The "Performance Testing" section describes what types of tests were performed but does not provide the numerical acceptance criteria or the reported performance outcomes beyond qualitative statements (e.g., "assuring cannula integrity", "Qualitatively verify activation").
Furthermore, the document does not describe a study involving human readers or comparative effectiveness studies (MRMC) as it is a medical device for injecting viscoelastic fluid, not an AI/imaging diagnostic device.
Here's an attempt to answer your questions based only on the provided document, highlighting where information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific numerical acceptance criteria and reported performance values (e.g., precise strength values, exact force measurements, or quantitative pass/fail rates for functional tests) are not detailed in this document. The document lists the types of tests performed to ensure the device meets design specifications and conformance to standards.
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary from Document) |
|---|---|
| Joint Strength Testing | Cannula integrity assured for anticipated forces during use. Tensile strength and bend testing performed using Instron with validated methods. Priming port interface confirmed qualitatively through simulated use and visual inspection. |
| Drivetrain Motion Functional Testing | Activation of Actuator Button causes desired drivetrain motion, visually verified during multiple actuations. Mechanism resets for maximum number of cycles recommended in IFU. |
| Actuator Button Force | Quantitative test measured force required to fully depress Actuator Button using Instron. Units visually verified to dispense fluid and reset for maximum cycles recommended. |
| Dispense Volume Testing | Quantitatively tested amount of dispensed viscoelastic fluid per Actuator Button activation for different fluids over maximum cycles recommended in IFU. (Specific volume per actuation: ~7 µL reported in Device Description section) |
| Leak Testing | Fluid pathway seals and duckbill valve quantitatively tested via 100% pressure decay tests during sample build. |
| Cadaver Evaluation | Qualitatively verified delivery using viscoelastic fluid dyed with Trypan Blue on cadaver eyes. |
| Human Factors Engineering | Evaluation utilizing 15 surgeons in simulated surgical suite, working through all stages of unpacking, presenting to sterile field, priming and using device per label/instructions for use. |
| Biocompatibility | Assessment within a risk management framework per ISO 10993-1. Tests include Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation/Intracutaneous Reactivity (21 CFR 58), Acute Systemic Toxicity (ISO 10993-11), Material-Mediated Pyrogenicity (ISO 10993-11 & USP 43-NF 38). |
| Chemical Characterization | Testing of materials per EN ISO 10993-18:2009. |
| Package Integrity | Demonstrated per EN ISO 11607-1/2 after sterilization, distribution simulation, and environmental conditioning. Samples aged in compliance to ASTM F1980-16. Tests include visible inspection (ASTM F1886-16), seal strength (ASTM F88-15), and seal integrity (ASTM F2096-11). |
| Luer Fitting Compliance | Priming port, female luer connection, confirmed compliance to ISO 80369-7:2016. |
| Stainless Steel Cannula Compliance | Compliance to ISO 9626:2016. |
2. Sample size used for the test set and the data provenance
The document does not specify exact numerical sample sizes for most of the performance tests (e.g., "100% of units during sample build" is mentioned for drivetrain motion, but no number of units is given). For Human Factors Engineering, "15 surgeons" were used.
Data provenance (e.g., country of origin, retrospective/prospective) is not stated. These tests are likely laboratory-based functional and material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device and the provided document. The ground truth for functional engineering tests, material science tests, and biological safety is established by adherence to recognized international and national standards, and by engineering specifications, rather than expert consensus on diagnostic interpretations. The "experts" involved would be the engineers, test technicians, and possibly medical professionals (for cadaver evaluation and human factors) conducting these specific tests. For the Human Factors Engineering evaluation, 15 surgeons were used. Their specific qualifications beyond being "surgeons" are not detailed.
4. Adjudication method for the test set
This is not applicable as the tests described are primarily objective engineering and material science evaluations against predefined mechanical, biological, and material specifications, not subjective assessments requiring 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted diagnostic tools, not for a surgical instrument like the Streamline® Viscoelastic Injector.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The Streamline® Viscoelastic Injector is a manually operated surgical device, not an algorithm.
7. The type of ground truth used
The ground truth for the performance testing is based on:
- Established engineering specifications (e.g., required force for actuation, dispensed volume).
- Compliance with recognized international and national standards (e.g., ISO 10993 series for biocompatibility, ISO 80369-7 for Luer fittings, ISO 9626 for cannulas, ASTM standards for packaging).
- Qualitative assessment by trained personnel during functional checks (e.g., visual verification of drivetrain motion, qualitative verification on cadaver eyes).
8. The sample size for the training set
This is not applicable. The Streamline® Viscoelastic Injector is a mechanical surgical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 8, 2021
New World Medical, Inc. Victor Arellano Global Regulatory Affairs Manager 10763 Edison Court Rancho Cucamonga, California 91730
Re: K211680
Trade/Device Name: Streamline® Surgical System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH, HMX Dated: August 27, 2021 Received: September 1, 2021
Dear Victor Arellano:
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.
for LCDR Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K211680
Device Name Streamline® Viscoelastic Injector
Indications for Use (Describe)
The Streamline® Viscoelastic Injector is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.
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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This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
Submitter Information
| 510(K) Owner Name: | New World Medical, Inc10763 Edison CourtRancho Cucamonga, CA 91730USA (909) 466-4304 |
|---|---|
| Contact Information: | Victor ArellanoGlobal Regulatory Affairs ManagerNew World Medical, Inc.Phone: (909) 466-4304 Ext118Email: varellano@newworldmedical.com |
October 7, 2021
Date Prepared:
Device Name and Classification
| Trade / Proprietary Name: | Streamline® Viscoelastic Injector | |
|---|---|---|
| Device Common Name: | Viscoelastic Injector | |
| Classification Names: | Pump, Infusion | Cannula, Ophthalmic |
| Regulation Numbers | 21 CFR 880.5725 | 21 CFR 886.4350 |
| Device Classification: | Class II | Class I |
| Product Codes | MRH (Infusion Pump, Ophthalmic) | HMX (Ophthalmic Cannula) |
| Predicate Device: | Image: box |
|---|---|
| ------------------- | ------------ |
| Device Name | 510(k) Number |
|---|---|
| OMNI™ Surgical System | K173332 |
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Intended Use
The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery.
Indications for Use
The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.
Device Description and Technological Characteristics
The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid.
The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision.
The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification.
Image /page/4/Picture/9 description: The image shows a white medical device with blue accents. The device has a dispensing cannula on the left side, an actuator button on the top, and a priming port on the right side. The device is labeled "STREAMLINE".
Image /page/4/Figure/10 description: The image shows the text "Figure 1" in a bold, sans-serif font. The word "Figure" is larger than the number "1". The text is black against a white background.
The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device.
The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2).
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Image /page/5/Picture/1 description: The image shows three different states of a dispensing canula. The first state is the tip in its initial state. The second state shows the dispensing canula deployed. The third state shows the viscoelastic fluid being dispensed.
Image /page/5/Figure/2 description: The image shows the text "Figure 2" in a bold, sans-serif font. The word "Figure" is on the first line, and the number "2" is on the second line. The text is black against a white background.
The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use.
Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.
Comparison of Technological Characteristics with the Predicate Device
The technical features of the Streamline® Viscoelastic Injector are substantially equivalent to the predicate device Sight Sciences Omni Surgical System (K173332).
The Streamline® Viscoelastic Injector and predicate device Sight Sciences Omni Surgical is a manually operated device for the controlled delivery of small amounts of viscoelastic fluid and dispenses these fluids based on the principle of exchanging volumes much like a syringe.
The following Table 2 compares the attributes of the Streamline® Viscoelastic Injector with the predicate device.
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| Characteristic | NWM Streamline® ViscoelasticInjector(Subject Device) | OMNI™ SurgicalSystem(Primary Predicate)K173332 |
|---|---|---|
| Class | II | II |
| Product Code | Primary: MRH (Ophthalmic InfusionPump, Class II) | Primary: MRH (Ophthalmic InfusionPump) |
| Secondary: HMX (Class I, Exempt) forOphthalmic Cannulas | Secondary: HMZ(Trabeculotome) | |
| Regulation | Primary: 880.5725(Infusion Pump) | Primary: 880.5725(Infusion Pump) |
| Secondary: 886.4350(ManualOphthalmicsurgical instrument) | Secondary: 886.4350(Manualophthalmic surgical instrument) | |
| Intended Use | Delivery of small amounts of viscoelasticfluid during Ophthalmic Surgery | Delivery of small amounts of viscoelasticfluid during Ophthalmic Surgery Creationof incisions within the trabecularmeshwork. |
| Indications forUse | The Streamline® Viscoelastic Injector isasingle-use disposablecannula for useduring ophthalmic surgical procedures todeliver small amounts of viscoelasticfluid. | The OMNI™ Surgical System is amanually operated device for delivery ofsmall amounts of viscoelastic fluid, forexample Healon® or Healon GV® fromAbbott Medical Optics (AMO),Amvisc®from Bausch & Lomb, or PROVISC®from Alcon, during ophthalmic surgery. Itis also indicated to cut trabecularmeshwork tissue duringtrabeculotomyprocedures. |
| TechnicalCharacteristics | • Cannula• Internal reservoir• Plunger tube• Actuator Button | • Cannula• Microcatheter• Internal reservoir• Plunger tube• Finger wheel |
| Characteristic | NWM Streamline® ViscoelasticInjector(Subject Device) | OMNI™ SurgicalSystem(Primary Predicate)K173332 |
| Target Anatomy | Anterior Chamber | Schlemm's Canal/TrabecularMeshwork |
| OperatingPrinciple | Manual | Manual |
| Design / MechanismofAction | • Lumen has a round, bolus, atraumatic tipfordispensing of viscoelastic.• Retractable medical grade transparentcolored outer sleeve to enhance visibilityundermagnification.• Proximal handledesigned forambidextrous use.• Handle has internalviscoelastic reservoirand plunger tube• Finger actuated buttonfor retractingsleeve anddispensing viscoelastic fluid.• Device cannula is long enough to reachacross the eye180 degrees from the cornealincision.• Device dispensing cannula has opposingoutlets at an acute angleto dispenseviscoelasticfluid.• Device actuation button provides audibleclick when activating. | • Stainless-steel cannulahas sharp tip thatcan beused to pierce the trabecularmeshwork and provide access intoSchlemm's canal. Minordimensionalchanges to cannula tip height and radius• Flexible microcatheterwith rounded,atraumatic tip for dispensing of viscoelastic• Microcatheter is bluecolor to facilitate itsvisibility in Schlemm'scanal as it isadvanced/retracted through the cannula• Microcatheter allowsaccess to 360° ofSchlemm's canal in two 180° segments• Proximal handle changed to ovoid shapewith elastomeric material for added grip• Proximal handle allows ambidextrous useineither patient eye• Internal viscoelastic reservoir and plungertube with dimensionalchanges to allowdispensing ofviscoelastic |
| Characteristic | NWM Streamline® ViscoelasticInjector(Subject Device) | OMNI™ SurgicalSystem(Primary Predicate)K173332 |
| • Ovoid handle shape allows advancementwheels (finger wheels) to be reduced to twoforadvancing and retracting microcatheterup to 20mm using a rack and pinionmechanism• Tactile and audible clicks indicate preciseadvancement• Viscoelastic dispensedduring retraction offirsttwo cycles after priming withviscoelastic fluid• Flexible microcatheterintroduced intoSchlemm's canal and pulled through to cuttrabecular meshwork• Priming Lock moved to accommodate newLuerfitting and prevents accidentaldispensing during viscoelastic priming• Changes were made to the materials in thehandle, reservoir, Luer fitting and newbonding adhesive wasused | ||
| Viscoelastic | Supplied separatelyfrom unaffiliatedmanufacturers.Viscoelastic loaded intodevice prior touse by attaching OVD cartridge directlyto a Luer fitting located at the proximalend of the device handle for easeofpriming. | Cohesive viscoelasticfluid(OVD or ophthalmic viscosurgical device)issupplied separately.Viscoelastic loaded into device (primed)prior to use by attachingOVD cartridgedirectly to a Luer fitting that replaces thecap on proximal end of OMNIdevice handlefor ease of priming |
| Characteristic | NWM Streamline® Viscoelastic Injector(Subject Device) | OMNI™ SurgicalSystem(Primary Predicate)K173332 |
| Sterile andSingleUse | Provided sterile. Singleuse. | Provided sterile. Singleuse. |
| Passive orEnergized Deviceto DispenseViscoelastic | Passive | Passive |
| DispensingControl | Manual depression ofActuator Button todispense viscoelastic fluid | After priming, viscoelastic dispensingcontrol occurs through manual rotationofeither advancement wheel at the distal endof the device.Synchronization of the two wheels wasreversed for ease of use |
| DispensingMechanism | Syringe (Volumeexchange) | Syringe (Volumeexchange) |
| OVD VolumeDispensed | 7 µL | 11 µL |
| Materials | Medical grade materialsincluding:• Cannula - StainlessSteel• Polycarbonate tipsleeve• ABS molded primingport Silicone seals | Medical grade materials,including ABS,polycarbonate,stainless steel, silicone, parylene coating,cyanoacrylate, acrylate edurethane,polyimide |
| Interface | Handheld | Handheld |
| Catheter / CannulaShaft/ Probe OD | 150 microns | 483 microns |
| MicrocatheterTipOuter Diameter | ≤ 0.007 inches(< 178 microns) | 0.0090 to 0.0110 inches(229 to 279 microns) |
Table 2 – Streamline® Attribute Comparison
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Performance Testing
Extensive non-clinical testing of the Streamline® Viscoelastic Injector has been performed to fulfill the traceability of design input and output matrix addressing all relevant test criteria for the device type. The requirements are driven by established standards and include the following:
Functional Performance Testing, Design Verification
Testing was based on all applicable standards, as well as, testing to demonstrate conformance to design specifications. Test samples exposed to maximum gamma sterilization simulation, environmental conditioning, and accelerated aging for 1-year shelf life.
- . Joint Strength Testing
- Quantitative tensile strength testing of all patient interfacing cannula and over-molded polymer O joints using Instron with validated test methods, assuring cannula integrity for anticipated forces during use.
- Bend testing of patient interfacing cannula under maximum expected loading during use, using O Instron with validated test method.
- Strength of priming port interface qualitatively confirmed for all test units through simulated use O and visual inspection under protocol.
- Drivetrain motion functional testing ●
- Oualitatively verify activation of the Actuator Button causes the desired drivetrain motion via O visual inspection during multiple button actuations, with one side housing removed (100% of units during sample build).
- Verify Maximum Recommended Cycles Qualitatively verify activation of Actuator Button O results in fluid being dispensed and mechanism resets for maximum number of cycles recommended in IFU.
- . Actuator Button force.
- Quantitative test measuring force required to fully depress Actuator Button using Instron, O validated test method, and a range of viscoelastic fluids.
- Visually verify units dispense fluid and the mechanism resets for maximum number of cycles O recommended in the IFU.
- Dispense volume testing ●
- Ouantitatively test under validated test methods measuring amount of dispensed viscoelastic fluid O per Actuator Button activation for different viscoelastic fluids over maximum number of cycles recommended in the IFU.
- Leak Testing ●
- Quantitatively test fluid pathway seals and duckbill valve via 100% pressure decay tests during O sample build.
- Cadaver evaluation ●
- Qualitatively verify delivery using viscoelastic fluid dyed with Trypan Blueon cadaver eyes. O
- . Human Factors Engineering Evaluation
- Human Factors Engineering evaluation utilizing 15 surgeons in simulated surgical suite, working O through all stages of unpacking, presenting to sterile field, priming and using device per label/ instructions for use.
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- . Biocompatibility
- Biocompatibility assessment within a risk management framework per ISO 10993-1 Fifth Edition O 2018-08. The following tests will be completed:
- Cytotoxicity as per the requirements established in ISO 10993-5, Biological Evaluation of O Medical Devices -- Part 5, Annex C : MTT Cytotoxicity test.
- Sensitization as per the requirements established in 10993-10. Biological Evaluation of Medical O Devices -- Part 10: Tests For Irritation And Skin Sensitization.
- Irritation or Intracutaneous Reactivity in accordance with FDA GLP Regulations, 21 CFR 58 O
- Acute Systemic Toxicity as per the requirements established in 10993-11, Biological Evaluation O of Medical Devices -- Part 11: Tests for Systemic Toxicity.
- Material-Mediated Pyrogenicity as per the requirements established in 10993-11, Biological O Evaluation of Medical Devices -- Part 11: Tests For Systemic Toxicity, and USP 43-NF 38 General Chapter <151 >, Pyrogen Test.
- Chemical characterization testing of materials per EN ISO 10993-18:2009. .
- Package Integrity for 1-year shelf life ●
- Demonstration of package integrity per EN ISO 11607-1 and 2:2019, Requirements for materials, O sterile barrier systems and packaging systems. after maximum gamma sterilization, distribution simulation and environmental conditioning. Samples aged in compliance to ASTM F1980-16
- Visible inspection of seals per ASTM F1886-16
- Seal strength per ASTM F88-15 ●
- Seal integrity per ASTM F2096-11 ●
- Demonstration of package integrity per EN ISO 11607-1 and 2:2019, Requirements for materials, O sterile barrier systems and packaging systems. after maximum gamma sterilization, distribution simulation and environmental conditioning. Samples aged in compliance to ASTM F1980-16
- . Luer Fitting Compliance
- Priming port, female luer connection, confirmed compliance to ISO 80369-7:2016 O
- Stainless Steel Cannula compliance to ISO 9626:2016
Substantial Equivalence
The Streamline® Viscoelastic Injector meets all product design requirements and applicable standards. The Streamline® Viscoelastic Injector has the same key technological characteristics, and principle of operation as the predicate device. Therefore, the device has been shown to be substantially equivalent to the predicate device.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).