(255 days)
The Biowy PICC catheter S Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi. The catheter is available in a kit configuration.
The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters. The catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device. The Catheter is provided in a kit with multiple components that includes a stylet, torque adapter and T-lock to facilitate catheter insertion and flushing which are subject to this submission. The stylet has a torque adapter at the end to facilitate handling and withdrawal of the stylet. The catheter and other components in the kit are unchanged from the predicate device.
This document is a 510(k) Pre-market Notification for a medical device (Biowy PICC Catheter S Kit), not a study proving a device meets AI-related acceptance criteria. Therefore, most of the requested information regarding AI acceptance criteria and study design for AI performance evaluation is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device (Biowy PICC Catheter K173956) based on non-clinical bench testing for the physical catheter and its new accessories.
Here's the information that can be extracted, and where the requested information is not applicable (N/A) because the document describes a traditional medical device clearance, not an AI/ML powered device:
Device: Biowy PICC Catheter S Kit (K192246)
Type of Device: Percutaneous, implanted, long-term intravascular catheter (PICC)
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Tests" and "Results" which indicate whether the device "Passed" or "Met requirements" for various physical and material properties. These are not acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
| Test | Standards | Acceptance Criteria (Implied by "Passed/Met Requirements") | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 | Meets ISO 10993-1 requirements | Passed / met requirements |
| Sterility Assurance Level (SAL) | ISO 11135-1:2014 | SAL of 10-6 | 10-6 |
| Particulates | USP <788> | Meets USP <788> requirements | Passed / met requirements |
| Stylet Inspections and Lock Test | Internal | Meets internal specifications | Passed / met requirements |
| Catheter Burst test after stylet insertion | ISO 10555-1:2013 | Meets ISO 10555-1:2013 requirements | Passed / met requirements |
| Stylet Adapter Tensile Test | ISO 10555-1:2013 | Meets ISO 10555-1:2013 requirements | Passed / met requirements |
| Stylet-Adapter Separation Force | ISO 10555-1:2013 | Meets ISO 10555-1:2013 requirements | Passed / met requirements |
| Stylet performance | ISO 10555-1:2013 / Internal | Meets ISO 10555-1:2013 and internal specifications | Passed / met requirements |
| Stylet - Materials | ASTM 138-13 | Meets ASTM 138-13 requirements | Passed |
Since this is not an AI-powered device, the following points are Not Applicable (N/A) to the information provided in the document:
2. Sample size used for the test set and the data provenance: N/A (No AI test set described)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No AI ground truth establishment described)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No AI test set described)
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: N/A (Not an AI-assisted device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI algorithm)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Ground truth as understood for AI performance is not relevant here. "Ground truth" for this device's performance is based on physical property testing and material standards.)
8. The sample size for the training set: N/A (No AI training set described)
9. How the ground truth for the training set was established: N/A (No AI training set described)
Summary for this document: The provided text is a 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence through non-clinical bench testing of the device's physical properties and materials against established medical device standards. It does not involve artificial intelligence, machine learning, or associated performance metrics and study designs that would typically address the questions posed about AI acceptance criteria and studies.
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April 30, 2020
Biowy Corporation Arthur Lu President 27031 Vista Terrace Lake Forest, California 92630
Re: K192246
Trade/Device Name: Biowy PICC Catheter S Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: March 27, 2020 Received: March 31, 2020
Dear Arthur Lu:
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,
For Tina Kiang, Ph.D. 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) K192246
Device Name
Biowy PICC Catheter S Kit
Indications for Use (Describe)
The Biowy PICC catheter S Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi. The catheter is available in a kit configuration.
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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Biowy Corporation
Biowy PICC Catheter S Kit
Traditional 510(k)
K192246 510(k) Summary
-
- Submitter Information
| Submitter Name: | Biowy Corporation |
|---|---|
| Address: | 27031/27002 Vista TerraceLake Forest, CA 92630 |
| Telephone No. | 1-(949) 305-8211 |
| Fax Number: | 1-(866) 506-5094 |
Primary Contact: Arthur Lu Email: alu@biowy.com
Date of Preparation:
April 28,2020
-
- Device Information
Device Name: Biowy PICC Catheter S Kit Trade Name: Biowy PICC Catheter S Kit Model numbers: PICC4SK-S and PICC5DK-S Common/Usual Name: Peripherally Inserted Central Catheter (PICC) Regulation Description: Percutaneous, implanted, long-term intravascular catheter Requlation Number: 21 CFR 880.5970 Device Class = Product Code: LSS Classification Panel: General Hospital
- Device Information
3. Predicate Devices:
Predicate Name: Biowy PICC Catheter Trade Name: Biowy PICC Catheter Peripherally Inserted Central Catheter (PICC) Common/Usual Name: Regulation Description: Percutaneous, implanted, long-term intravascular catheter Regulation Number 21 CFR 880.5970 Product Code: LJS Device Class: ll Premarket Notification: K173956 Biowy Corporation Manufacturer
4. Device Description:
The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters. The catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual
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lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device. The Catheter is provided in a kit with multiple components that includes a stylet, torque adapter and T-lock to facilitate catheter insertion and flushing which are subject to this submission. The stylet has a torque adapter at the end to facilitate handling and withdrawal of the stylet. The catheter and other components in the kit are unchanged from the predicate device.
5. Indications for Use
| Primary predicate | Subject device |
|---|---|
| K173956 | K192246 |
| The Biowy PICC Catheter is indicated forshort or long term peripheral access to thecentral venous system for intravenoustherapy and power injection of contrastmedia. For blood sampling, infusion ortherapy, use 4 French or larger catheter. Themaximum recommended infusion rate is5ml/sec for power injection of contrast media.The maximum pressure of power injectorsused with the Biowy catheter may not exceed300psi. | The Biowy PICC Catheter S Kit is indicatedfor short or long term peripheral access to thecentral venous system for intravenoustherapy and power injection of contrastmedia. For blood sampling, infusion ortherapy, use 4 French or larger catheter. Themaximum recommended infusion rate is5ml/sec for power injection of contrast media.The maximum pressure of power injectorsused with the Biowy catheter may not exceed300psi. The catheter is available in a kitconfiguration. |
6. Technological Comparison to Predicate
| Element Comparison | PredicateK173956 | Subject DeviceK192246 |
|---|---|---|
| Device Name | Biowy PICC Catheter | Biowy PICC Catheter S Kit |
| Regulatory Class | II | II |
| Classification | 21 CFR 880.5970 | 21 CFR 880.5970 |
| Product Code | LJS | LJS |
| CatheterNeedleGuidewireMicrointroducerSyringeNeedleless valve/capDrapeTrayWrapMeasure tape | 4Fr x 55cm Single Lumen5Fr x 60cm Double lumen | Unchanged from the predicate K173956 |
| Additional Componentsin Kit | Not provided | T-Lock (Tuohy Burst Adapter)Stylet (stainless steel)Torque Adapter (cleared in K922536) |
| Biocompatibility | 10993-1 | 10993-1 |
| Sterilization | Ethylene Oxide | Same |
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The subject device (single lumen 4F and dual lumen 5F) are examined using the same testing requirements as the predicate. A stylet is added in the catheter to support and facilitate catheter insertion. A T-lock is provided to lock the stylet with the catheter and to facilitate flushing. The stylet has a torque adapter at the end to facilitate handling and withdrawal of the stylet. Biocompatibility and performance of the new features are evaluated and meet the requirements for their intended use. The new feature does not add a new question of safety and effectiveness.
The comparison above shows substantial equivalence between the subject device and the predicate.
7. Summary of Non-Clinical Testing
- . FDA Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters 1995
- . 10555-1 Second Edition 2013-06-15 Intravascular Catheters -- Sterile and Single-Use Intravascular Catheters -- Part 1: General Requirements
- FDA Guidance for Industry 2016: Use of International Standard ISO 10993-1, "Biological . evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Performance data gathered in design verification testing demonstrated that Biowy PICC Catheter S Kit is substantially equivalent to the predicate Biowy PICC Catheter and the risk associated with use of the new device have been adequately mitigated.
The performance tests are listed below to demonstrate substantial equivalence of the subject device K173956 (4F SL and 5F DL), and applicable standards. A risk assessment in conformance to ISO 14971 was performed.
| Test | Standards | Results |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Passed / met requirements |
| Sterility Assurance Level (SAL) | ISO 11135-1:2014 | 10-6 |
| Particulates | USP <788> | Passed / met requirements |
| Stylet Inspections and Lock Test | Internal | Passed / met requirements |
| Catheter Burst test after stylet insertion | ISO 10555-1:2013 | Passed / met requirements |
| Stylet Adapter Tensile Test | ISO 10555-1:2013 | Passed / met requirements |
| Stylet-Adapter Separation Force | ISO 10555-1:2013 | Passed / met requirements |
| Stylet performance | ISO 10555-1:2013Internal | Passed / met requirements |
| Stylet -Materials | ASTM 138-13 | Passed |
Brief discussion of the non-clinical tests submitted for a determination of substantial equivalence:
The Biowy PICC catheter used in the subject device is identical to that in the predicate device Biowy PICC Catheter. The catheter was designed, made of the same polymer materials, use the same technological manufacturing methods, and have the same intended use as the predicate devices. Biowy has conducted bench performance testing. There are no differences in technological
characteristics (including flow rate, burst pressure, lumens, and the distal end configurations) of catheter compared to the predicate. The only difference between the subject device and the predicate device is that the subject has three additional accessories used for catheter placement. Biocompatibility and performance tests of the additional components including stylet insertion, catheter burst, tensile, flexibility, and torque strength
are evaluated and meet the requirements for their intended use. Therefore, the subject devices are
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substantially equivalent to the predicate device. The indications for use is similar. The indications for use for the subject device states that it is available in a kit configuration.
8. Conclusion
The addition of the Stylet, T-Lock, and Torque adapter in the Biowy PICC Catheter S Kits (Model number PICC4SK-S and PICC5DK-S) met all the predetermined performance acceptance criteria of the testing performed. The addition of these components does not change the intended use of the device and, based on FDA's decision tree, is considered substantially equivalent to the predicate device: the Biowy PICC catheter, K173956.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”