(434 days)
Not Found
No
The device description and performance studies focus on the physical components, materials, and sterilization of standard IV administration sets, with no mention of AI or ML capabilities.
No.
The device administers fluid but does not perform therapeutic action itself. It is a delivery system, not a treatment.
No
Explanation: The device is an IV administration set designed for fluid delivery into a patient's vascular system, not for diagnosis. Its intended use is purely for administering fluid.
No
The device description clearly outlines physical components such as tubing, spikes, drip chambers, filters, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "For administration of fluid from a container into the patient vascular system through a vascular access device." This describes a device used for delivering substances directly into the body, not for examining specimens taken from the body to provide information about a physiological state, health, or disease.
- Device Description: The description details components like spikes, drip chambers, tubing, flow regulators, and connectors. These are all parts of a system for delivering fluids intravenously.
- Anatomical Site: The anatomical site is the "patient vascular system," which is within the living body. IVDs typically analyze samples taken from the body.
- Performance Studies: The performance studies focus on aspects like compliance with standards for IV administration sets, biocompatibility, shelf life, and human factors related to using the device for fluid delivery. These are not studies related to diagnostic performance (like sensitivity, specificity, etc.).
- Predicate Device: The predicate device listed is an "Intravascular Administration Set," which is consistent with the function of delivering fluids into the vascular system, not performing an in vitro diagnostic test.
In summary, the device's function, components, intended use, and the nature of the performance studies all point to it being a device for administering fluids in vivo (within the body), not for performing diagnostic tests in vitro (outside the body).
N/A
Intended Use / Indications for Use
For administration of fluid from a container into the patient vascular system through a vascular access device.
Product codes
FPA
Device Description
The Polyfusion IV Administration Sets are available in multiple configurations. In more detail:
Polyfusion NFV IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The set may include a vented or non-vented universal spike, drip chamber, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 µm inline filter, slide clamp, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 15 drops/ml and 60 drops/ml. Different lengths are available, from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.
Polyfusion Air Stop IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The inclusion of an air stop filter maintains a constant fluid level in fluid delivery tubing and reduces the possibility of air entering the line when the I.V. bottle/bag is empty. The set may include a vented or non-vented universal spike, drip chamber, air stop filter, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 um inline filter, slide clamps, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 20 drops/ml and 60 drops/ml. Different lengths are available from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Non-clinical testing of the Polyfusion IV Administration Sets has included successful compliance testing with the following standards, most of which are FDA-recognized:
- ISO 8536-4:2019, FDA recognition # 6-447
- ISO 8536-14:2016, not FDA recognized
- ISO 80369-7:2021, FDA recognition # 5-97
- USP Method 1, not FDA recognized
- ISTA-3A:2018, FDA recognition # 5-126
- ASTM F-1886 / F-1886-M-16, FDA recognition # 14-501
- ASTM F-2096, FDA recognition # 14-359
- ASTM F-1929, FDA recognition # 14-484
- EN 868-5:2018, not FDA recognized
- Microbial Ingress testing
Biocompatibility of components in direct or indirect contact with the patient has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018, while taking into consideration relevant FDA guidance, including:
- Cytotoxicity (ISO 10993-5:2009, FDA recognition # 2-245)
- Sensitization (ISO 10993-10:2010, FDA recognition # 2-174)
- Irritation or intracutaneous reactivity (ISO 10993-10:2010. FDA recognition # 2-174)
- Acute systemic toxicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Subacute/subchronic toxicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Material mediated pyrogenicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Hemocompatibility (ISO 10993-4:2017, FDA recognition # 2-248)
Sterilization and shelf life:
Sterilization of the Polyfusion admin sets is achieved by use of a validated ethylene oxide gas cycle, achieving a sterilization assurance level (SAL) of 10-6. Ethylene oxide residuals are within specified limits.
A shelf life of 5 years has been established by testing the sterile packaging following accelerated aging (per ASTM F 1980-16) in accordance with the following standards:
- ISO 8536-4:2019, FDA recognition # 6-447
- ISO 8536-14:2016, not FDA recognized
- ISO 80369-20:2015, FDA recognition # 5-97
- USP 2012, not FDA recognized
- ASTM F-1929, FDA recognition # 14-484
- ASTM F-2096, FDA recognition # 14-359
- ASTM F-88 / F88M-15, FDA recognition # 14-482
- USP 2012, FDA recognition # 14-561
Human factors:
A human factors study has also been carried out in accordance with ISO 23908:2011, while taking into consideration relevant FDA guidance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2023
Poly Medicure Limited % Roger Gray VP Quality and Regulatory Donawa Lifescience Consluting Srl Piazza Albania 10 Rome, 00153 Italy
Re: K220312
Trade/Device Name: Polyfusion IV Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 13, 2023 Received: March 14, 2023
Dear Roger Gray:
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
1
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 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,
Danil Walloschek
David Wolloscheck, Ph.D. Acting 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220312
Device Name Polyfusion IV Administration Sets
Indications for Use (Describe)
For administration of fluid from a container into the patient vascular system through a vascular access device.
Type of Use (Select one or both, as applicable)
| Transaction with ID of 21 CFR 201 Subpart D | For Use Consistent with 21 CFR 201 Subpart D |
|---|---|
| ------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------- |
X | 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 is a logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a yellow circle containing a red cross in the middle of the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller font. Underneath that, the phrase "We Care As We Cure" is written in teal.
K220312 510(k) Summary
| Device Name: | Polyfusion IV Administration Sets |
|---|---|
| Type of 510(k) submission: | Traditional |
| Preparation Date: | April 12, 2023 |
| Manufacturer: | Poly Medicure Ltd |
| PA 010-018, 010-019, | |
| Mahindra World City (Jaipur) Ltd, | |
| Multi Product SEZ, Jaipur | |
| Rajasthan-302237 | |
| India | |
| Phone: | +91-129-3355070 |
| FDA Establishment Reg. Number: | 9616991 |
| Owner/Operator Reg. Number: | 9044462 |
| 510(k) Owner and Submitter: | Poly Medicure Ltd |
| PA 010-018, 010-019, | |
| Mahindra World City (Jaipur) Ltd, | |
| Multi Product SEZ, Jaipur | |
| Rajasthan-302237 | |
| India | |
| 510(k) Contact: | Mr Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome | |
| Italy | |
| Phone: | |
| Fax: | |
| Email: | +39 06 578 2665 |
| +39 06 574 3786 | |
| rgray@donawa.com | |
| FDA Product Code: | FPA |
| FDA Regulation Number: | 21 CFR 880.5440 |
| FDA Classification Name: | Intravascular administration set |
| Classification Panel: | General Hospital |
| Common Name: | Intravascular Administration Set |
| FDA Classification: | Class II |
| Submission Type: | 510(k) |
| Indications for Use: | For administration of fluid from a container into the patient vascular |
| system through a vascular access device. |
4
Image /page/4/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a red cross inside of a yellow circle. Below the logo is the text "We Care As We Cure".
Device Description:
The Polyfusion IV Administration Sets are available in multiple configurations. In more detail:
Polyfusion NFV IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The set may include a vented or non-vented universal spike, drip chamber, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 µm inline filter, slide clamp, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 15 drops/ml and 60 drops/ml. Different lengths are available, from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.
Polyfusion Air Stop IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The inclusion of an air stop filter maintains a constant fluid level in fluid delivery tubing and reduces the possibility of air entering the line when the I.V. bottle/bag is empty. The set may include a vented or non-vented universal spike, drip chamber, air stop filter, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 um inline filter, slide clamps, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 20 drops/ml and 60 drops/ml. Different lengths are available from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.
Performance data:
Non-clinical testing of the Polyfusion IV Administration Sets has included successful compliance testing with the following standards, most of which are FDA-recognized:
- ISO 8536-4:2019, FDA recognition # 6-447
- ISO 8536-14:2016, not FDA recognized
- ISO 80369-7:2021, FDA recognition # 5-97 ●
- USP Method 1, not FDA recognized ●
- ISTA-3A:2018, FDA recognition # 5-126 ●
- ASTM F-1886 / F-1886-M-16, FDA recognition # 14-501 ●
- . ASTM F-2096, FDA recognition # 14-359
- ASTM F-1929, FDA recognition # 14-484 ●
- EN 868-5:2018, not FDA recognized
- . Microbial Ingress testing
Biocompatibility:
Biocompatibility of components in direct or indirect contact with the patient has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018, while taking into consideration relevant FDA guidance, including:
- Cytotoxicity (ISO 10993-5:2009, FDA recognition # 2-245)
- Sensitization (ISO 10993-10:2010, FDA recognition # 2-174)
- Irritation or intracutaneous reactivity (ISO 10993-10:2010. FDA recognition # 2-174) ●
- Acute systemic toxicity (ISO 10993-11:2017, FDA recognition # 2-255) ●
- Subacute/subchronic toxicity (ISO 10993-11:2017, FDA recognition # 2-255) ●
- Material mediated pyrogenicity (ISO 10993-11:2017, FDA recognition # 2-255) ●
- Hemocompatibility (ISO 10993-4:2017, FDA recognition # 2-248) .
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Image /page/5/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a yellow circle containing a red cross in the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in smaller, gray letters. Underneath that is the phrase "We Care As We Cure" in teal.
Sterilization and shelf life:
Sterilization of the Polyfusion admin sets is achieved by use of a validated ethylene oxide gas cycle, achieving a sterilization assurance level (SAL) of 10-6. Ethylene oxide residuals are within specified limits
A shelf life of 5 years has been established by testing the sterile packaging following accelerated aging (per ASTM F 1980-16) in accordance with the following standards:
- ISO 8536-4:2019, FDA recognition # 6-447 ●
- ISO 8536-14:2016, not FDA recognized ●
- ISO 80369-20:2015, FDA recognition # 5-97
- USP 2012, not FDA recognized ●
- ASTM F-1929, FDA recognition # 14-484 ●
- ASTM F-2096, FDA recognition # 14-359
- ASTM F-88 / F88M-15, FDA recognition # 14-482 ●
- USP 2012, FDA recognition # 14-561 .
Human factors:
A human factors study has also been carried out in accordance with ISO 23908:2011, while taking into consideration relevant FDA guidance.
Substantial equivalence:
The predicate device selected for comparison with the Polyfusion IV administration Admin Sets is:
| Predicate Device: | Intravascular Administration Set |
|---|---|
| Sponsor: | Baxter Healthcare Corp. |
| 510(k) Number: | K203609 |
| Clearance Date: | 30 September 2021 |
| FDA Product Code: | FPA |
| Classification Name: | Intravascular Administration Set |
| Regulation No: | 21 CFR 880.5440 |
| Class: | II |
Predicate device comparison table:
The following Table 1 provides evidence of substantial equivalence of the subject device with the selected predicate device.
| Table 1: Predicate device comparison table | |||
|---|---|---|---|
| Feature | Subject device | Predicate device | Similarity |
| Device name | Polyfusion IV Administration Sets | Intravascular Administration Sets | N/A |
| Device | |||
| Manufacturer | Poly Medicure, India | Baxter Healthcare Corporation | N/A |
| 510(k) Reference | This submission | K203609 | N/A |
| FDA Product Code | FPA | FPA | Same |
| FDA Classification | |||
| Name | Intravascular Administration Set | Intravascular Administration Set | Same |
| FDA Regulation | |||
| Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
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Image /page/6/Picture/0 description: The image is a logo for Polymed Medical Devices. The logo is teal and features a yellow circle with a red cross in the center. Below the logo, the words "MEDICAL DEVICES" are written in a smaller font. Below that, the words "We Care As We Cure" are written in a slightly larger font.
| Table 1: Predicate device comparison table | |||
|---|---|---|---|
| Feature | Subject device | Predicate device | Similarity |
| Device description: | Available in multiple configurations | ||
| that may include different materials | |||
| in contact with delivered fluid, | |||
| different lengths and drip rates and | |||
| different valves and secondary | |||
| access ports | Available in multiple configurations | ||
| that may include different materials | |||
| in contact with delivered fluid, | |||
| different lengths and drip rates and | |||
| different valves and secondary | |||
| access ports | Same | ||
| Gravity feed only? | Yes | No, maybe used with infusion pump | Different |
| Comment #1 | |||
| Indications for use | For administration of fluid from a | ||
| container into the patient vascular | |||
| system through a vascular access | |||
| device. | For the administration of fluids from | ||
| a container into the patient's | |||
| vascular system through a vascular | |||
| access device. | Same | ||
| Material in contact | |||
| with delivered fluid | Either PVC not made with DEHP, or | ||
| material not made with either PVC or | |||
| DEHP (TPE and TPO) | Either PVC made with DEHP, or | ||
| PVC not made with DEHP | Different | ||
| Comment #2 | |||
| Vented/non-vented | |||
| spike | Option for both | Option for both | Same |
| Lengths | 196 to 276 cm | 175.26 to 339.09 cm | Different |
| Comment #3 | |||
| Drip rates | 10 to 60 drips per minute | 10 drips per minute | Different |
| Comment #4 | |||
| Priming volume | Approx 25 ml | 6.1 to 21.2 ml | Different |
| Comment #5 | |||
| Single use | Yes | Yes | Same |
| Sterile | Yes, SAL 10-6 | Yes, SAL 10-6 | Same |
| Sterilization | |||
| method | Ethylene oxide | Radiation | Different |
| Comment #6 | |||
| Shelf life | 5 years | 2 years | Different |
| Comment #7 | |||
| Biocompatibility | Biocompatible in accordance with | ||
| ISO 10993 series and FDA guidance | Biocompatible in accordance with | ||
| ISO 10993 series and FDA guidance | Same | ||
| Performance | |||
| standards | ISO 8536-4:2019 | ||
| ISO 8536-14:2016 | |||
| ISO 80369-20:2015 | |||
| USP Method B | |||
| Microbial ingress | ISO 594-1 | ||
| ISO 594-2 | |||
| ISO 80369-7:2016 | |||
| USP Method 1 | |||
| Microbial ingress | Similar | ||
| Prescription use? | Rx only | Rx only | Same |
Substantial Equivalence discussion
The subject device and the predicate device have many identical, similar or substantially equivalent properties or features. The differences that exist and are identified in the above table are explained in the following paragraphs.
Comment #1: Gravity feed
The subject device is indicated for gravity feed use only, whereas the predicated for both gravity feed and feed via an infusion pump. While the predicate device offers an alternative to gravity feed use, when used for gravity feed, the two devices have very similar characteristics and specifications, with no new or different questions of safety or effectiveness being raised that would affect the substantial equivalence of the two devices.
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Image /page/7/Picture/0 description: The image is a logo for a company called POLYMED. The logo is composed of the word "POLYMED" in teal, with a yellow circle containing a red cross in the middle of the "O". Below the word "POLYMED" are the words "MEDICAL DEVICES" in a smaller, gray font. Below that is the phrase "We Care As We Cure" in a teal, cursive font.
Comment #2: Material in contact with delivered fluid
While both the subject device range and the predicate device range include sets in which the material in contact with delivered fluid is 'DEHP-free PVC', there is a material difference between the other sets in the two ranges. In this respect, the predicate device range includes material which is PVC manufactured with DEHP, while the subject device range includes non-PVC materials which do not include DEHP. These materials are a thermoplastic elastomer (TPE) and a thermoplastic polyolefin (TPO). This difference has been shown by the results of bench tests carried out in accordance with international, FDA-recognized, standards, to not raise any new or different questions of safety or effectiveness that would affect the substantial equivalence of the two device ranges.
Comment #3: Available lengths
The predicate device range includes admin sets that have shortest lengths and longer longest lengths than the subject device range, but these differences are not significant in terms of safety and effectiveness, with the set lengths being substantially equivalent.
Comment #4: Drip rates
The subject device range includes a variety of drip rates, whereas the predicate device range has only one stated drip rate, which is equivalent to the lowest drip rate available within the subject device range. While the subject device offers alternative drip rates, when used at 10 drips/min, the two devices have very similar characteristics and specifications, with no new or different questions of safety or effectiveness being raised that would affect the substantial equivalence of the two devices.
Comment #5: Priming volume
There is a difference in priming volume between the subject device range and predicate device range, with the subject device range having a single stated priming volume for all variants, while the predicate device range includes different priming volumes for different variants. No new or different questions of safety or effectiveness are raised by this difference that would affect the substantial equivalence of the two device ranges.
Comment #6: Sterilization
The subject device is sterilized by means of ethylene oxide, whereas the predicate device is sterilized by means of radiation. Both sterilization methods result in a validated Sterility Assurance Level (SAL) of 10-6, so the devices are substantially equivalent in this respect with no new or different questions of safety or effectiveness being raised.
Comment #7: Shelf life
The subject device has a validated shelf life of five years, compared with the two year shelf life validated for the predicate device. This difference in shelf life raises no new or different questions of safety or effectiveness that would affect the substantial equivalence of the two devices.
Performance standards
The subject device has been tested in accordance with newer international standards than the predicate device, but the purposes and scope of the standards used for both subject and predicate devices are the same or similar, with no new or different questions of safety or effectiveness being raised that would affect the substantial equivalence of the two devices.
Conclusion
The subject and predicate devices have very similar indications for use and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices are addressed by means of specific features present in the reference devices. These differences do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.