(169 days)
The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.
The device is not intended to store the fluids for 24 hours or greater.
The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use.
The proposed device is available in 7 series due to different bag capacities, different tube locations and different tube materials.
The provided text describes the 510(k) premarket notification for the "Disposable Infusion Bag for Parenteral Nutrition" (K222622) and compares it to a predicate device (K101412). However, it focuses on non-clinical tests and does not include information about clinical studies with human readers or AI performance metrics. Therefore, several sections of your request cannot be fulfilled by the provided document.
Here's an analysis based on the available text:
1. Table of acceptance criteria and the reported device performance
The document lists performance standards met by the proposed device, which serve as acceptance criteria. The "reported device performance" is a statement that the device complied with these standards. Specific numerical results or detailed performance metrics are not provided in this summary.
| Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|
| ISO 15747-2018: Plastic containers for intravenous injections | Complied with the standard |
| ASTM F1886 / F1886M-16: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | Complied with the standard |
| ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility) | Complied with the standard |
| ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration | Complied with the standard |
| ISO 10993-5:2009: Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity | Complied with the standard (Meet requirements for ISO 10993-1) |
| ISO 10993-10:2010: Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization | Complied with the standard (Meet requirements for ISO 10993-1) |
| ISO 10993-11:2017: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Complied with the standard (Meet requirements for ISO 10993-1) |
| ISO 10993-4:2017: Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood | Complied with the standard (Meet requirements for ISO 10993-1) |
| USP <151>: Pyrogen Test | Complied with the standard |
| USP <85>: Bacterial Endotoxins Test | Complied with the standard |
| ISO 10993-7:2008: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (Incl. Tech Corrigendum 1 (2009), Amendment 1 (2019)) | Complied with the standard |
| USP <71>: Sterility Tests | Complied with the standard |
| ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems | Complied with the standard |
| Biocompatibility: Meet requirements for ISO 10993-1 | Met requirements for ISO 10993-1 |
| Sterility: SAL 10-6, ETO | SAL 10-6, ETO (Same as predicate) |
| Performance of filling for BEDX series (different design) | Showed it can be filled |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria consists of a series of non-clinical tests conducted by the manufacturer, Beijing L&Z Medical Technology Development Co., Ltd. These tests aimed to verify that the proposed device met all design specifications and complied with established international and US national standards relevant to medical devices, particularly for I.V. containers.
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for each non-clinical test performed. It generally states that "Non clinical tests were conducted," implying that an appropriate number of samples were tested to achieve statistical confidence for each standard.
- Sample sizes: Not specified in the provided summary.
- Data provenance: The tests were conducted by the manufacturer, Beijing L&Z Medical Technology Development Co., Ltd., which is located in Beijing, P.R. China. The tests are non-clinical, meaning they involve laboratory or bench testing rather than human subjects. They are inherently prospective in the context of device development and verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the described study is a non-clinical device performance test, not a study involving interpretation by human experts or ground truth in the context of diagnostic performance (e.g., radiology). The "ground truth" here is adherence to the specified technical and biological safety standards.
4. Adjudication method for the test set
This section is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or when establishing ground truth from expert opinions.
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 submission is for a physical medical device (infusion bag), not an AI-powered diagnostic or assistive technology. Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for this device's performance is defined by the established international and national standards (e.g., ISO 15747, ASTM F1886, ISO 10993 series, USP <151>) and the specific design specifications of the device. The compliance with these objective, measurable standards constitutes the "ground truth" that the non-clinical tests were designed to verify.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no training set in the context of data used to train a model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 16, 2023
Beijing L&Z Medical Technology Development Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K222622
Trade/Device Name: Disposable Infusion Bag for Parenteral Nutrition Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: Class II Product Code: KPE Dated: December 21, 2022 Received: January 17, 2023
Dear Diana Hong:
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
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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 (OS) 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222622
Device Name
Disposable Infusion Bag for Parenteral Nutrition
Indications for Use (Describe)
The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.
The device is not intended to store the fluids for 24 hours or greater.
| 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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510(k) Summary - K222622
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K222622
-
- Date of Preparation: 2/9/2023
-
- Sponsor Identification
Beijing L&Z Medical Technology Development Co., Ltd.
N0.8, M2-5 Block, Xinggu Industrial Developing Zone, Pinggu District 101200 BEIJING, P.R. CHINA.
Establishment Registration Number: None
Contact Person: QiuHong Dong Position: Product Registry Manager Tel: +86-10-69956211 Fax: +86-10-69956800 Email: dqh(@lingze.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
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-
- Identification of Proposed Device
Trade Name: Disposable Infusion Bag for Parenteral Nutrition Common Name: I.V. Container
- Identification of Proposed Device
Regulatory Information Classification Name: I.V. Container Classification: II Product Code: KPE Regulation Number: 21 CFR 880.5025 Review Panel: General Hospital
-
- Identification of Predicate Device
510(k) Number: K101412 Product Name: EVA TPN bag
- Identification of Predicate Device
-
- Indications for Use:
The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The device is not intended to store the fluids for 24 hours or greater.
- Indications for Use:
-
- Device Description:
The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use.
- Device Description:
The proposed device is available in 7 series due to different bag capacities, different tube locations and different tube materials.
| Model | Location of injection port | Location of infusion port | Location of inlet tube | Inlet tube material |
|---|---|---|---|---|
| BEAE series | Below EVA bag | Below EVA bag | Below EVA bag | EVA |
| BEAP series | Below EVA bag | Below EVA bag | Below EVA bag | PVC |
| BEBE series | Below EVA bag | Below EVA bag | Above EVA bag | EVA |
| BEBP series | Below EVA bag | Below EVA bag | Above EVA bag | PVC |
| BECE series | Above EVA bag | Below EVA bag | Above EVA bag | EVA |
| BECP series | Above EVA bag | Below EVA bag | Above EVA bag | PVC |
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| BEDX series | 2 injection ports | 1 infusion port / | / | |
|---|---|---|---|---|
| below EVA bag | below EVA bag |
- For model BEAE series, BEAP series, BEBE series, BEBP series and BECP series, the device has the inlet tube with spike, injection port and infusion port. The bags are filled by connecting them to containers through standard spikes. Additional medications can be added to the container using an injection port. After filling, the containers can be attached to an intravascular administration set via the infusion port.
- For model BEDX series, the device has two injection ports and one infusion port, and doesn't have the inlet tube with clamp. The bags are filled by injecting them into one of the injection port using a syringe. Additional medications can be added to the container using another injection port. After filling, the containers can be attached to an intravascular administration set via the infusion port.
| Table 1 General Comparison | |||
|---|---|---|---|
| ITEM | Proposed Device | Predicate Device K101412 | Remark |
| Product Name | Disposable Infusion Bag for ParenteralNutrition | EVA TPN bag | / |
| Product Code | KPE | KPE | Same |
| Regulation No. | 880.5025 | 880.5025 | Same |
| Class | II | II | Same |
| Classification Name | I.V. Container | I.V. Container | Same |
| Indications for Use | The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.The device is not intended to store the fluids for 24 hours or greater. | The EVA TPN bag is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. | Same |
| Single-Use | Yes | Yes | Same |
Summary of Technological characteristics 8.
| Table 2 | Safety and Effectiveness Comparison |
|---|---|
| --------- | ------------------------------------- |
| ITEM | Proposed Device | Predicate Device K101412 | Remark |
|---|---|---|---|
| Product Name | Disposable Infusion Bag for ParenteralNutrition | EVA TPN bag | / |
| Design | The Disposable Infusion Bag forParenteral Nutrition is provided in two | The empty bags are filledby connecting them to | Different |
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| configurations: | containers through | |||
|---|---|---|---|---|
| - For model BEAE series, BEAP series, BEBE series, BEBP series, BECE series and BECP series, the device has the inlet tube with spike, injection port and infusion port. The bags are filled by connecting them to containers through standard spikes. Additional medications can be added to the container using an injection port. After filling, the containers can be attached to an intravascular administration set via the infusion port. | standard spikes.Additional medications can be added to the container using a medication port.After filling, the containers can be attached to an intravascular administration set via the set port. | |||
| - For model BEDX series, the device has two injection ports and one infusion port, and doesn't have the inlet tube with clamp. The bags are filled by injecting them into one of the injection port using a syringe. Additional medications can be added to the container using another injection port. After filling, the containers can be attached to an intravascular administration set via the infusion port. | ||||
| Volume Capacity (mL) | Model | Volume | ||
| BEAE series | 100, 125, 150, 200, 250, 300, 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000, 5000 | 150 to 5000 | ||
| BEAP series | 100, 125, 150, 200, 250, 300, 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000, 5000 | |||
| BEBE series | 1500, 2000, 2500, 3000, 3500, 4000, 5000 | |||
| Different | ||||
| BEBP series | 1500, 2000, 2500,3000, 3500, 4000,5000 | |||
| BECE series | 1500, 2000, 2500,3000, 3500, 4000,5000 | |||
| BECP series | 1500, 2000, 2500,3000, 3500, 4000,5000 | |||
| BEDX series | 100, 125, 150, 200 | |||
| Material | Copolyoxymethylene MC-90 (POM);Low-Density Polyethylene (LDPE);Acrylonitrile-Butadiene-Styrene (ABS);Polypropylene (PP);Ethylene Vinyl Acetate Copolymer (EVA);Poly(vinyl chloride) Resin (PVC);Trioctyl Trimellitate (TOTM);Methyl methacrylate-Acrylonitrile-Butadiene-St yrene Copolymer;Polycarbonate and Isoprene Rubber;Polycarbonate and Butyl Rubber;Acrylic Copolymer;White Masterbatch;Blue Masterbatch | Different | ||
| EVA, phthalate-free ethyl vinyl acetate plastic;Plastic, no components made of natural rubber latex (use of isoprene);PVC with DEHP plasticizer DEHP FREE PVC | ||||
| Biocompatibility | Meet requirements for ISO 10993-1 | Meet requirements for ISO 10993-1 | ||
| Sterility | SAL 10-6, ETO | SAL 10-6, ETO |
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Different - Design
The design for the proposed device is different from that of the predicate device. The proposed device is provided in two configurations. For model BEAE series, BEBE series, BEBP series, BECE series and BECP series, the proposed device has the same configuration and functions as the predicate device, except that the configuration is named differently. For model BEDX series, the proposed device does not have the inlet tube with clamp. The proposed device is filled through one of the injection ports. Although the bag is not filled in the same way as the predicate device, the performance test has been performed on the proposed device, and the test result shows that the proposed device can be filled. Therefore, this difference will not raise new questions on safety and
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effectiveness of the proposed device.
Different - Volume Capacity
The volume capacity of the proposed device is different from that of the predicate device, and the proposed device offers more options. The bag is used to store nutritional formula. Different volume devices will be selected by physician per patient's condition. Performance test has been performed on the proposed device, and the test result shows that the proposed device will perform as intended. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.
Different - Material
The material of the proposed device is different from that of the predicate device. However, the biocompatibility test has been performed on the proposed device and the test results show that the materials of proposed device will not have an adverse effect on the patient. Therefore, this difference will not raise new question on the new safety and effectiveness of the proposed device.
9. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 15747-2018 Plastic containers for intravenous injections
-
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility)
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- A ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
-
USP <151> Pyrogen Test
-
USP <85> Bacterial Endotoxins Test
-
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
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- ア USP <71> Sterility Tests
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is substantially equivalent to the predicate K101412.
- Conclusion
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).