(109 days)
Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products to a patient's vascular system.
Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space.
Sapphire Sets are intended for use with the Sapphire Infusion System. Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, filter, in-line adapter, injection site assembly, check valve, pressure activated valve and blood chamber. Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.
The provided text describes the 510(k) summary for "Sapphire Sets," which are administration sets intended for use with the Sapphire Infusion System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than detailing the performance of an AI/ML-driven medical device. Therefore, a direct answer to the request regarding acceptance criteria and study proving performance for an AI/ML device, as outlined in the prompt, cannot be fully provided from this document.
The document discusses non-clinical tests for the infusion set components, assuring their material and functional integrity, and their compatibility with the Sapphire Infusion System. It does not refer to AI/ML device performance or associated studies like MRMC or standalone algorithm performance.
However, I can extract information related to the closest aspects from the document:
1. Table of acceptance criteria and reported device performance:
The document doesn't provide a typical "acceptance criteria vs. reported performance" table like one would expect for an AI/ML algorithm with metrics like sensitivity, specificity, or AUC. Instead, it lists the types of non-clinical tests performed to demonstrate that the new Sapphire Sets perform as intended and meet applicable standards, confirming they are "acceptable."
| Acceptance Criteria (Applicable Test Requirements) | Reported Device Performance |
|---|---|
| Material Testing (Biocompatibility) | |
| ISO 10993-4 Hemocompatibility | Met (All testing is acceptable) |
| ISO 10993-5 Cytotoxicity | Met (All testing is acceptable) |
| ISO 10993-10 Sensitization/Intracutaneous Irritation | Met (All testing is acceptable) |
| ISO 10993-11 Systemic Toxicity/Subacute Toxicity | Met (All testing is acceptable) |
| Pyrogenicity | Met (All testing is acceptable) |
| Functional Performance Testing | |
| ISO 8536-4.6.1 Particulate Contamination | Met (All testing is acceptable) |
| ISO 8536-4.6.2 Leakage | Met (All testing is acceptable) |
| ISO 8536-8.6.3 (Leakage) | Met (All testing is acceptable) |
| ISO 8536-4.6.3 Tensile Strength | Met (All testing is acceptable) |
| ISO 8536-4.6.4 Coring | Met (All testing is acceptable) |
| ISO 8536-4.6.9 Flow Regulator | Met (All testing is acceptable) |
| ISO 1135-4.5.8 Flow Regulator | Met (All testing is acceptable) |
| Flow rate accuracy testing with Sapphire Infusion System | Met (All testing is acceptable) |
| Sterility Assurance | |
| Sterility Assurance Level (SAL) | 10^-6 |
2. Sample size used for the test set and the data provenance:
This document does not specify a "test set" in the context of an AI/ML algorithm validating against a dataset. The testing described is for physical properties and functionality of medical device components. The document implies laboratory testing of device samples. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of device submission.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable. Ground truth for an AI/ML algorithm involving expert review is not relevant to the physical and functional testing of an infusion set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an image-based or diagnostic AI/ML device where adjudication methods for ground truth would be used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This type of study is for evaluating human performance (e.g., radiologists) with and without AI assistance, which is not applicable to an infusion set.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This document is not about an AI/ML algorithm.
7. The type of ground truth used:
The 'ground truth' for the Sapphire Sets relates to established engineering standards (e.g., ISO standards for material properties, leakage, tensile strength, flow rate accuracy) and biological safety tests. It's based on objective, quantitative measurements and adherence to recognized industry standards, rather than expert consensus on diagnostic interpretations or clinical outcomes in the way an AI/ML model's performance would be assessed.
8. The sample size for the training set:
Not applicable. This document is not about an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable. This document is not about an AI/ML algorithm.
In summary: The provided document is a 510(k) premarket notification for a medical device (infusion sets) demonstrating substantial equivalence to predicate devices, primarily through engineering and material testing, and compliance with established standards. It does not describe the evaluation of an AI/ML medical device as outlined in the prompt's detailed questions.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
ICU Medical Amy Giertych Vice President. Global Regulatory Affairs 600 North Field Drive Lake Forest, Illinois 60045
Re: K171346
Trade/Device Name: Sapphire Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ Dated: July 27, 2017 Received: July 27, 2017
Dear Amy Giertych:
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. 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
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Tara A. Ryan -S
for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name Sapphire Set
Indications for Use (Describe)
Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular.
Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.
Sapphire Epidural Set are indicated for the delivery of fluids to a patient's epidural space.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for Sapphire Sets.
| Submitter Information | |
|---|---|
| Name | ICU Medical |
| Address | 600 North Field DriveLake Forest, IL. 60046 |
| Phone number | (224)-212-4235 |
| Mobile number | (224)-507-8812 |
| Fax number | (224) 212-5221 |
| Establishment RegistrationNumber | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | Amy Giertych, Vice President Global Regulatory Affairs |
| Date prepared | 8/23/2017 |
| Name of device | |
| Trade or proprietary name | Sapphire Sets |
| Common or usual name | Accessories, Pump, Infusion |
| Classification name | Infusion Pump, 21 CFR 880.5725, Class II |
| Product Code(s) | Primary Code: MRZ |
| Legally marketed device(s) to whichequivalence is claimed | Sapphire Infusion System - K123049 (Primary Predicate 510(k))Sapphire Sets - K160492 (Reference 510(k))Plum Sets - K141789 (Reference 510(k)) |
| Reason for 510(k) submission | New IV administration sets to be used with Q Core Medical Ltd.'s Sapphire Infusion System. |
| Device description | Sapphire Sets are intended for use with the Sapphire Infusion System. Sapphire sets arecomprised of various components including the following: male luer adapter with cap, femaleluer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, filter, in-line adapter, injection site assembly, check valve, pressure activated valve and blood chamber.Sapphire sets are configured to ensure the intended use of the device is met. The sets aredisposable devices for single patient use. |
| Intended Use of Device | Sapphire sets are intended for use with the Sapphire Infusion System to deliver fluids from acontainer to a patient's vascular system. |
| Indication for use | Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient'svascular system.Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to bloodand blood products to a patient's vascular system.Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient'sepidural space. |
{4}------------------------------------------------
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Predicate 510(k) | Proposed Device |
| Indications for Use | The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products.The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment. The Sapphire pump is designed to follow the patient through the various care areas, and is suitable for use in the different settings. The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only. | Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system.Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products to a patient's vascular system.Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. |
| Characteristic | Predicate/Reference 510(k) | Proposed Device |
| Design and Materials of Construction | The design and materials of construction of all components for the sets, are as cleared under predicate/reference 510(k) noted below for each set component. | The design and materials of construction for all set components listed below have been previously cleared under the associated predicate/reference 510(k) |
| Piercing Pin | Piercing Pin | |
| new | 75-0704 | |
| K160492 (reference 510(k)) | 85-0143 | |
| K160492 (reference 510(k)) | 85-0142 | |
| K160492 (reference 510(k)) | 85-0288 | |
| K160492 (reference 510(k)) | 67-1760 | |
| K160492 (reference 510(k)) | 90-5710 | |
| Female Adapter | Female Adapter | |
| K160492 (reference 510(k)) | 90-9674 | |
| Male Adapter | Male Adapter | |
| K160492 (reference 510(k)) | 85-0250 | |
| Cap/Hood | Cap/Hood | |
| K160492 (reference 510(k)) | 75-0042 | |
| K160492 (reference 510(k)) | 75-0735 | |
| K160492 (reference 510(k)) | 75-2322 | |
| K160492 (reference 510(k)) | 90-9664 | |
| Characteristic | Predicate/Reference 510(k) | Proposed Device |
| K160492 (reference 510(k)) | 90-9665 | |
| Cassette | Cassette | |
| K160492 (reference 510(k)) | 85-0239 | |
| K160492 (reference 510(k)) | 67-2115 | |
| Tubing | Tubing | |
| K160492 (reference 510(k)) | 75-0322 | |
| K160492 (reference 510(k)) | 75-0324 | |
| K160492 (reference 510(k)) | 75-0364 | |
| K141789 (reference 510(k)) | 75-0941 | |
| K160492 (reference 510(k)) | 75-5236 | |
| Flow Control | Flow Control | |
| K141789 (reference 510(k)) | 67-1942 | |
| K160492 (reference 510(k)) | 75-1004 | |
| K160492 (reference 510(k)) | 75-1099 | |
| K160492 (reference 510(k)) | 96-4509 | |
| K141789 (reference 510(k)) | 96-4882 | |
| In-Line Adapter | In-Line Adapter | |
| K141789 (reference 510(k)) | 75-4967 | |
| K160492 (reference 510(k)) | 90-6979 | |
| Injection Site | Injection Site | |
| K160492 (reference 510(k)) | 67-2060 | |
| Check Valve | Check Valve | |
| K160492 (reference 510(k)) | 67-1042 | |
| K160492 (reference 510(k)) | 67-1589 | |
| Filter | Filter | |
| K141789 (reference 510(k)) | 67-1659 | |
| K141789 (reference 510(k)) | 67-1721 | |
| PAV | PAV | |
| K123049 (predicate 510(k) | 67-2098 | |
| Blood Chamber | Blood Chamber | |
| K141789 (reference 510(k)) | 85-0189 | |
| Bonding Agents | Bonding Agents | |
| K160492 (reference 510(k)) | 52-0010 | |
| K160492 (reference 510(k)) | 52-0013 | |
| K160492 (reference 510(k)) | 52-0166 |
{5}------------------------------------------------
{6}------------------------------------------------
| Summary of non-clinical testsfor determination of substantialequivalence | All materials of construction for Q CoreSapphire Sets meet the applicable materialtest requirements for ISO 10993 asdemonstrated in the predicate 510(k). | All materials of construction for Sapphire Setsremain the same as the predicate product.Additional data has been generateddemonstrating that Sapphire sets meet theapplicable material test requirements for ISO10993 as follows:ISO Standard Biological Effect 10993-4 Hemocompatibility 10993-5 Cytotoxicity 10993-10 SensitizationIntracutaneous Irritation 10993-11 Systemic ToxicitySubacute ToxicityPyrogenicity | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Performance testing for all Q CoreSapphire set components was conducted asindicated in the predicate 510(k) to ensurethe device performs as intended inaccordance with applicable standards. | New performance data has been generated toensure the Sapphire Sets perform as intendedin accordance with:ISO 8536-4. 6.1 Particulate Contamination ISO 8536-4. 6.2/ Leakage ISO 8536-8.6.3 ISO 8536-4.6.3 Tensile Strength ISO 8536-4.6.4 Coring ISO 8536-4.6.9 Flow Regulator ISO 1135-4.5.8 Flow Regulator Additionally, flow rate accuracy testing usingthe proposed Sapphire Sets and the SapphireInfusion System has been conducted. | |||||||||||||||
| All testing is acceptable. | All testing is acceptable. | |||||||||||||||
| The product Sterility Assurance Level is10-6. | The product Sterility Assurance Levelis 10-6 |
Conclusion
Sapphire Sets meet the functional claims and intended use as described in the product labeling. Sapphire Sets are 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).