(114 days)
The Early Bird is indicated for the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures.
The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.
The Saranas Early Bird Bleed Monitoring System (Early Bird) is a single use, disposable, Ethylene Oxide sterilized medical device. The Early Bird now claims a 2-year shelf life.
The Early Bird consists of the following: introducer sheath, user interface display (UID), for the early detection and monitoring of potential internal bleeding complications (IBCs), and a compatible dilator as shown in Figure 1.
The Early Bird introducer sheath contains four embedded electrodes on the cannula and a hemostasis valve located within the sheath hub. The distal end of the sheath has a tapered leading edge which transitions smoothly to the tapered dilator, forming an atraumatic device. The dilator is radiopaque to aid in visibility under fluoroscopy during insertion.
The Early Bird electrodes are connected via conductors, which transverse an independent lumen in the flush line, to a battery powered impedance analyzer, which resides in the User Interface Display (UID), depicted in Figure 2. The Early Bird is designed to monitor changes in bioimpedance due to extravascular fluid accumulation in the region where the device is inserted into the body during a percutaneous endovascular procedure.
The document K230273 describes the Saranas Early Bird Bleed Monitoring System, an intravascular bleed monitor, and its modifications. Here's a summary of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list specific quantifiable "acceptance criteria" in a table format for its modified algorithm's performance on human data. Instead, it describes the modifications to the algorithm and the verification that these modifications function as intended. The "reported device performance" is indicated by the overarching statement that "Verification results all passed, indicating that the enhanced algorithm provides an alternate Level 1 bleed detection which triggers upon an impedance drop threshold from a baseline impedance value." This implies that the new detection mechanism was successfully implemented and demonstrated to trigger under the specified conditions.
However, based on the description of the device's function, we can infer some implied performance goals:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Performance of Enhanced Algorithm: | |
| - Level 1 bleed detection upon an impedance drop threshold from a baseline impedance value. | "Verification results all passed, indicating that the enhanced algorithm provides an alternate Level 1 bleed detection which triggers upon an impedance drop threshold from a baseline impedance value." |
| - Level 1 bleed detection upon a bioimpedance drop rate exceeding a slope threshold (identical to predicate). | The document states this criterion is "identical to the predicate device trigger criterion" and implies continued functional performance, as the new algorithm "augments" rather than replaces the existing one. "Verification results all passed" supports this. |
| - Level 3 detections function the same as in the predicate version of the firmware. | "Once the Level 1 bleed is activated by either detection scheme, the Level 3 detections function the same as in the predicate version of the firmware." This implies successful verification of this unchanged functionality. |
| Improved Power On Self-Test: | |
| - Reduced erroneous faults after activation due to widened upper limit of calibration self-check. | "The modified device has an improved power on self-test upon activation, which allows for confirming the functional health of the device with a reduction of false error indications. Specifically, the upper limit of the calibration self-check was widened to reduce erroneous faults after activation." |
| Reset Functionality: | |
| - Ability for users to reset the EBBMS detection algorithm. | "The enhanced firmware also provides an opportunity for users to reset the EBBMS detection algorithm at their discretion." The instructions for use (IFU) changes explicitly detail the reset procedure: "Briefly, at the physician's discretion, pressing the power button for seven (7) seconds, anytime five (5) minutes after activation, initiates the reset action as indicated by all three Bleed Monitoring Indicators (red LEDs) flashing once per second. A successful reset is confirmed by all indicators flashing once and a brief audible tone identical to the power on sequence of the predicate and modified device (i.e., power on sequence unchanged)." |
| No New Concerns for Safety or Effectiveness: | "The subject device does not introduce any new concerns for safety or effectiveness with the firmware changes." "Risk analysis and assessment were conducted... In summary, there were no unacceptable risks due to device operation because of the algorithm changes." "The software design verification and validation activities and regression testing provide a high degree of assurance for safety and effectiveness that the device performs as intended. These design controls demonstrate reliable results and risk controls that form the basis for substantial equivalence between the designs of the modified Early Bird and the cleared Early Bird (DEN180021)." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "design validation activities centered around existing data sets from the Early Bird animal validation study."
- Sample Size: The exact sample size for this "test set" (existing data sets from the animal validation study) is not specified in the provided text.
- Data Provenance: The data is from an "Early Bird animal validation study." The country of origin and whether it was retrospective or prospective are not specified, but it was an animal study, not human.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. Given that the validation was based on "existing data sets from the Early Bird animal validation study," the ground truth likely refers to the actual presence or absence of bleeds in the animal models, perhaps determined by direct observation, imaging, or post-mortem examination. The role or number of experts involved in establishing this ground truth for the animal study is not mentioned.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not discussed or indicated in the provided text. The evaluation focused on technical verification and validation of the algorithm's functional changes against existing animal study data.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone evaluation of the algorithm's performance was done. The "design verification activities centered around existing Early Bird software and electrical verification test protocols and acceptance criteria" and "design validation activities centered around existing data sets from the Early Bird animal validation study." This indicates that the algorithm's direct output was assessed against known outcomes in an animal model without human intervention as part of the primary evaluation of the firmware update.
7. The Type of Ground Truth Used:
The ground truth used was from an "Early Bird animal validation study." For an internal bleed monitor, the ground truth in such a study would typically be direct observation of extravascular fluid accumulation (bleeding) in the animal model, possibly through invasive surgical inspection, imaging techniques (e.g., ultrasound, CT), or post-mortem examination during the animal study. The document doesn't specify the exact method, but it is not pathology or human outcomes data for this firmware update validation.
8. The Sample Size for the Training Set:
The document focuses on a firmware update to an already cleared device (DEN180021). It does not provide information about the sample size of any training set used for the original algorithm development or for this specific modification. The validation for this update used "existing data sets from the Early Bird animal validation study" as the test set, implying the update itself might have been developed based on analysis of such data, but explicit training set size is not given.
9. How the Ground Truth for the Training Set Was Established:
As the document does not specify a training set or its size for this update, it does not describe how the ground truth for any training set was established.
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May 25, 2023
Saranas Inc. % Allison Komiyama Consultant RQM+ 2251 San Diego Ave. Suite B-257 San Diego, California 92110
Re: K230273
Trade/Device Name: Saranas Early Bird Bleed Monitoring System Regulation Number: 21 CFR 870.1345 Regulation Name: Intravascular bleed monitor Regulatory Class: Class II Product Code: QFJ Dated: January 31, 2023 Received: January 31, 2023
Dear Allison Komiyama:
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.
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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 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 medical devices and radiation-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.
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Saranas Early Bird Bleed Monitoring System
Indications for Use (Describe)
The Early Bird is indicated for the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures.
The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.
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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Image /page/3/Picture/0 description: The image shows the logo for "saranas." The word "saranas" is written in a light gray, sans-serif font. To the right of the word is a stylized image of a bird. The bird is red with a yellow beak and a purple wing.
510(k) Summary for the Saranas® Early Bird® Bleed Monitoring System
| Contact Information | |
|---|---|
| Manufacturer Name | Saranas, Inc.2450 Holcombe BoulevardSuite XHouston, Texas 77021,United States |
| Telephone: | (833) 375-9273 |
| Official Contact | Odell RobertsQuality Director |
| Consultant | Allison Komiyama, PhD, RACRQM+akomiyama@rqmplus.com |
| Telephone: | (412) 816-8253 |
510(k) Summary prepared on April 21, 2023
Regulatory Information
FDA identifies this generic type of device as:
Intravascular bleed monitor. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleed complications.
Regulation Number: 21 CFR 870.1345
Classification: II
Product Code: QFJ
Device Trade/Proprietary Name: Saranas® Early Bird® Bleed Monitoring System
Claim of Equivalence
Traditional 510(k) claiming equivalence to legally marketed device of same name:
Saranas® Early Bird® Bleed Monitoring System DE NOVO Submission Number: DEN180021
Date DE NOVO Classification Granted: March 1, 2019
Device Description
The Saranas Early Bird Bleed Monitoring System (Early Bird) is a single use, disposable, Ethylene Oxide sterilized medical device. The Early Bird now claims a 2-year shelf life.
The Early Bird consists of the following: introducer sheath, user interface display (UID), for the early detection and monitoring of potential internal bleeding complications (IBCs), and a compatible dilator as shown in Figure 1.
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Image /page/4/Picture/0 description: The image shows the logo for "Saranas". The text "saranas" is written in a light gray, lowercase font. To the right of the text is a stylized image of a bird. The bird is red with a yellow beak and a dark red wing.
FIGURE 1: Early Bird Bleed Monitoring System
Image /page/4/Figure/4 description: The image shows a medical device with several labeled components. The device includes a fully functional introducer sheath, a sheath hub with an internal hemostasis valve, and a bleed detection array with embedded electrodes. Additionally, the image identifies a standard flush line with a stopcock, a user interface display with visual and audible indicators, and a dilator.
The Early Bird introducer sheath contains four embedded electrodes on the cannula and a hemostasis valve located within the sheath hub. The distal end of the sheath has a tapered leading edge which transitions smoothly to the tapered dilator, forming an atraumatic device. The dilator is radiopaque to aid in visibility under fluoroscopy during insertion.
The Early Bird electrodes are connected via conductors, which transverse an independent lumen in the flush line, to a battery powered impedance analyzer, which resides in the User Interface Display (UID), depicted in Figure 2. The Early Bird is designed to monitor changes in bioimpedance due to extravascular fluid accumulation in the region where the device is inserted into the body during a percutaneous endovascular procedure.
FIGURE 2: Early Bird User Interface Display
Image /page/4/Figure/8 description: The image shows a Saranas Early Bird Bleed Monitoring System device. The device has several buttons and LED indicators, including a power button, power indicator, silence button, device error LED, and low battery LED. There are also three level indicators for bleed detection and progression.
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Image /page/5/Picture/0 description: The image shows the logo for "saranas". The word "saranas" is written in a light gray, lowercase font. To the right of the word is a stylized image of a red bird with a yellow beak. The bird is facing to the right.
Indications for Use
The Early Bird is indicated for the introduction of catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures.
The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.
Summary of Device Instructions for Use (IFU) Changes
- . A clarification was added to one device warning because of firmware changes.
- Sheath preparation directions for use included additional information: ●
- o The device is activated by pulling on the battery isolation pull tab before it is inserted into a patient for use and turned off after confirming a blinking green light.
- The device is reactivated by pressing the power button after the device is inserted into O the patient.
- Early Bird bioimpedance measurement reset functionality directions for use were added: .
- Briefly, at the physician's discretion, pressing the power button for seven (7) seconds, o anytime five (5) minutes after activation, initiates the reset action as indicated by all three Bleed Monitoring Indicators (red LEDs) flashing once per second.
- A successful reset is confirmed by all indicators flashing once and a brief audible tone o identical to the power on sequence of the predicate and modified device (i.e., power on sequence unchanged).
Technological Characteristics of Modified Device Versus Predicate Device
Some internal bleeding complications may progress slowly resulting in a rate of change of bioimpedance lower than the existing Early Bird Bleed Monitoring System (EBBMS) device's slope threshold. As a result, these slower bleeds may go undetected. This software release augments the detection algorithm by integrating an additional detection scheme based on an impedance drop threshold to supplement the current detection algorithm. The enhanced algorithm triggers a Level 1 bleed detection upon either an impedance drop threshold from a baseline impedance value or a bioimpedance drop rate that exceeds a slope threshold: the later trigger criterion being identical to the predicate device trigger criterion. Once the Level 1 bleed is activated by either detection scheme, the Level 3 detections function the same as in the predicate version of the firmware.
The modified device has an improved power on self-test upon activation, which allows for confirming the functional health of the device with a reduction of false error indications. Specifically, the upper limit of the calibration self-check was widened to reduce erroneous faults after activation. The enhanced firmware also provides an opportunity for users to reset the EBBMS detection algorithm at their discretion. Resetting the device is equivalent to activating a new device, reestablishing the bioimpedance baseline and enables further bleed detection and monitoring. The physical Early Bird device is unchanged from the firmware update. There are no changes to device materials or dimensions. There are no hardware changes to the Early Bird device related to the update of the firmware.
Below is a table that summarizes the technological characteristics of the device in this K230273 submission and compares these technological characteristics to the legally marketed Early Bird Bleed Monitoring System (DEN180021).
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Image /page/6/Picture/0 description: The image shows the logo for "saranas.". The word "saranas" is written in a light gray, sans-serif font. To the right of the word is a stylized image of a bird in red and pink with a yellow beak.
| Doc Number: | Re |
|---|---|
| Traditional 510(k) | |
| Submission | Pa |
| Subject Device(K230273) | Predicate Device(DEN180021) | Rationale for SubstantialEquivalence (SE) | |
|---|---|---|---|
| Sponsor | Saranas, Inc. | Saranas, Inc. | No change |
| Device Name | Saranas® Early Bird® BleedMonitoring System | Saranas® Early Bird® BleedMonitoring System | No change |
| DeviceRegulation /ClassificationName | 21 CFR 870.1345 IntravascularBleed Monitor | 21 CFR 870.1345 IntravascularBleed Monitor | No change |
| Product Code /Class | QFJ / Class II | QFJ / Class II | No change |
| Indications forUse | The Early Bird is indicated for theintroduction of catheters, catheterballoons, and other diagnostic andinterventional devices into thefemoral artery or femoral vein whilemaintaining hemostasis duringdiagnostic and interventionalendovascular procedures.The Early Bird provides physicianswith an early indication of a potentialinternal bleeding complication byinitial detection and monitoring of | The Early Bird is indicated for theintroduction of catheters, catheterballoons, and other diagnostic andinterventional devices into thefemoral artery or femoral vein whilemaintaining hemostasis duringdiagnostic and interventionalendovascular procedures.The Early Bird provides physicianswith an early indication of a potentialinternal bleeding complication byinitial detection and monitoring of | No change |
| extravascular fluid accumulation. | extravascular fluid accumulation. | ||
| Intended Use | The Early Bird is intended:• to be inserted into the femoralartery or femoral vein to provide aconduit for the insertion ofdiagnostic and interventionalendovascular devices.• to provide physicians with an earlyindication of extravascular fluidaccumulation, which may be due toa potential internal bleedingcomplication.• to detect and monitor changes inbioimpedance due to extravascularfluid accumulation, and to providephysicians with indications that apotential internal bleedingcomplication is progressing.The Early Bird is intended to providephysicians and other healthcareproviders with additional informationto aid in their clinical assessment ofthe patient during and afterendovascular procedures. As such,it is not intended to diagnose orreplace clinical judgment ofhealthcare professionals. | The Early Bird is intended:• to be inserted into the femoralartery or femoral vein to provide aconduit for the insertion of diagnosticand interventional endovasculardevices.• to provide physicians with an earlyindication of extravascular fluidaccumulation, which may be due to apotential internal bleedingcomplication.• to detect and monitor changes inbioimpedance due to extravascularfluid accumulation, and to providephysicians with indications that apotential internal bleedingcomplication is progressing.The Early Bird is intended to providephysicians and other healthcareproviders with additional informationto aid in their clinical assessment ofthe patient during and afterendovascular procedures. As such, itis not intended to diagnose orreplace clinical judgment ofhealthcare professionals. | No change |
| Shelf Life | 2 years | 1 year | Two-year real time aging andtwo-year accelerated agingvalidation studies, conductedin compliance with applicableISO and ASTM standards,verified that packaging andsterile barrier requirements,electrical performancerequirements, and mechanicalperformance requirementswere all met, demonstratingequivalent performance to thepredicate device. |
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Title: 510(k) Summary (K230273)
| Doc Number: | Revision: 0 |
|---|---|
| Traditional 510(k)Submission | Page 5 of 6 |
| Subject Device(K230273) | Predicate Device(DEN180021) | Rationale for SubstantialEquivalence (SE) | |
|---|---|---|---|
| DeviceWorkingLength (withdilator) | 20 cm (23 cm) | 20 cm (23 cm) | No change |
| Single-UseDevice? | Yes | Yes | No change |
| SterilizationMethod | Ethylene Oxide; SAL 10-6 | Ethylene Oxide; SAL 10-6 | No change |
| Power Source | 1 Alkaline 1.5V AAA battery | 1 Alkaline 1.5V AAA battery | No change |
| Battery Life | Up to 12 hours | Up to 12 hours | No change |
| ElectricalSafety | ME Equipment Class: InternallyPowered | ME Equipment Class: InternallyPowered | No change |
| Patient Connection: Type BF | Patient Connection: Type BF | ||
| Initial DeviceActivation | User interface display battery pulltab | User interface display battery pull tab | No change |
| InternalBleedingComplication(IBC) Indicators | Audible and Visual indicators (threelevels) | Audible and Visual indicators (threelevels) | No change |
| SoftwareVerification andValidationRequirementsMet? | Yes | Yes | The subject device does notintroduce any new concernsfor safety or effectivenesswith the firmware changes.The subject device and thepredicate devicedemonstrated to besubstantially equivalent. |
| Ability fordevice to bereset? | Yes | No | The reset allows the clinicianto initiate a new, real-timebleed monitoring session toaccount for situationsinvolving active bleeding, orwhen the device becomesaccidentally dislodged. Thereset restores the device tothe original factory settings.There is no change to theimpedance measurementmechanism or the IBCindicators, and therefore, thesubject device and thepredicate device demonstrateto be substantially equivalent. |
| Direct ContactBiocompatibilityTesting | Meets ISO 10993 | Meets ISO 10993 | No change |
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Image /page/8/Picture/0 description: The image shows the logo for "saranas." The word "saranas" is written in a light gray, sans-serif font. To the right of the word is a stylized image of a bird. The bird is red with a yellow beak and a purple wing.
Non-clinical Performance Data
Design controls were conducted in accordance with IEC 62304:2006, ISO 13485:2016, 21 CFR Part 820 and ISO 14971:2019. Design verification activities centered around existing Early Bird software and electrical verification test protocols and acceptance criteria (e.g., for the User Interface Display, Printed Circuit Board Assembly, and non-product tool data processor), and design validation activities centered around existing data sets from the Early Bird animal validation study. Verification results all passed, indicating that the enhanced algorithm provides an alternate Level 1 bleed detection which triggers upon an impedance drop threshold from a baseline impedance value. These design control activities demonstrate reliable results and risk controls that form the basis for substantial equivalence between the designs of the modified Early Bird and the cleared Early Bird (DEN180021).
Conclusions
Risk analysis and assessment were conducted in accordance with ISO 13485:2016 and ISO 14971:2019. In summary, there were no unacceptable risks due to device operation because of the algorithm changes.
The device algorithm change does not change existing device precautions, potential adverse events, and the essential performance statement within the Device Instructions for Use. Early Bird risk management documentation (hazards, failure modes, and effects analyses) was updated accordingly.
Possible device failure risk hazards have been mitigated through design verification and validation activities, and therefore, the risk level of possible device failure did not change.
The software design verification and validation activities and regression testing provide a high degree of assurance for safety and effectiveness that the device performs as intended. These design controls demonstrate reliable results and risk controls that form the basis for substantial equivalence between the designs of the modified Early Bird and the cleared Early Bird (DEN180021).
§ 870.1345 Intravascular bleed monitor.
(a)
Identification. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:
(i) Device performance characteristics;
(ii) Adverse effects, including gross necropsy and histopathology; and
(iii) Device usability, including device preparation, device handling, and user interface.
(2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Tensile testing of joints and materials;
(ii) Mechanical integrity testing;
(iii) Friction testing;
(iv) Flush testing;
(v) Air leakage and liquid leakage testing;
(vi) Latching and unlatching testing;
(vii) Kink and bend testing;
(viii) Insertion force testing;
(ix) Torque testing;
(x) Corrosion testing; and
(xi) Dimensional tolerance testing.
(3) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(5) The patient contacting components of the device must be demonstrated to be biocompatible.
(6) Software verification, validation, and hazard analysis must be performed.
(7) Performance data must demonstrate electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety.
(8) Human factors performance evaluation must demonstrate that the user can correctly use the device, based solely on reading the directions for use.
(9) Labeling must include:
(i) Instructions for use;
(ii) A shelf life and storage conditions;
(iii) Compatible procedures;
(iv) A sizing table; and
(v) Quantification of blood detected.