(144 days)
The Biowy PICC catheter 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 Biowy PICC catheters are opened-ended radiopaque polyurethane 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 provided document is a 510(k) summary for the Biowy PICC Catheter, which is a medical device and not an AI/ML software device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, number of experts for ground truth, adjudication methods, or training set details are not applicable in this context. The acceptance criteria and performance are based on physical and biological testing of the catheter.
Here's the information pulled from the document regarding the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test | Standards and Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Critical Dimensions | ISO 9626:2015 (Met requirements) | Passed and met requirement |
| Priming Volume | Internal (Met requirements) | Passed and met requirement |
| Tensile Force | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Elongation and Stiffness | Internal (Met requirements) | Passed and met requirement |
| Flexural Fatigue | Internal (Met requirements) | Passed and met requirement |
| Aspiration Flow/Catheter collapse | Internal (Met requirements) | Passed and met requirement |
| Air Leakage during Aspiration | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Gravity Flow | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Pump Flow | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Power Injection and Leak Testing | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Burst Pressure | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Power Injection/Burst Pressure | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Power Injection (10x)/Burst Pressure | ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
| Printing Marking | ISO 10555-3:2013 (Met requirements) | Passed and met requirement |
| 6% Luer Taper | ISO 594-1:1986 (Met requirements) | Passed and met requirement |
| Luer | ISO 594-1:1986, ISO 594-2:1998 (Met requirements) | Passed and met requirement |
| Luer Color Orientation | Internal (Met requirements) | Passed and met requirement |
| Radiopacity | ASTM F640-12 (Detectible) | Passed and met requirement |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizer |
| Irritation | ISO 10993-10 | Non-irritant |
| Acute Systemic Injection | ISO 10993-11 | Non-toxic |
| Material Mediated Pyrogen | USP <151> | Non-pyrogenic |
| LAL (Bacterial Endotoxins) | USP <85>, <161> | Passed and met requirements |
| Hemolysis (extract) | ISO 10993-4 | Non-hemolytic |
| Hemolysis (direct) | ISO 10993-4 | Non-hemolytic |
| Complement Activation | ISO 10993-4 (Similar to predicate) | Similar when compared to predicate |
| Partial Thromboplastin Time (PTT) | ISO 10993-4 (Minimal activator, same as predicate) | Minimal activator (same as predicate) |
| Dog Thrombogenicity | ISO 10993-4 (Similar to control) | Similar to control |
| Implantation | ISO 10993-6 | Non-irritant |
| Subacute/sub Chronic Toxicity, Genotoxicity, Chronic Toxicity, and Carcinogenicity | ISO 10993-17, ISO 10993-18 | Passed and met requirement |
| EtO sterilization | ISO 11135: 2014 (Met 10-6 SAL requirement) | Met 10-6 SAL requirement |
| Clinical Evaluation | Internal | Passed |
| Accelerated Aging (1.5 year, 3.0 year) | ISO 11607-1:2006, ASTM F88/F88M-15, ISO 10555-1:2014 (Met requirements) | Passed and met requirement |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test. The data provenance is not mentioned, and tests appear to be laboratory-based design verification rather than clinical data from human subjects. The study is a non-clinical performance test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a medical device clearance based on non-clinical performance testing and biocompatibility, not an AI/ML algorithm requiring expert ground truth for interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication is for studies involving human interpretation or assessments, such as in clinical trials or AI/ML evaluations.
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
Not applicable. This is for AI/ML software devices, not a physical medical device like a PICC catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI/ML software devices, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established engineering and biological standards (e.g., ISO, ASTM, USP). The device's performance is compared against these predetermined specifications and, in some cases for biocompatibility, against a legally marketed predicate device (5Fr DL PowerPICC® Catheter, K051672).
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 21, 2018
Biowy Corporation Andre Muller Regulatory Affairs and Quality Assurance Manager 27031/27002 Vista Terrace Lake Forest, California 92630
Re: K173956
Trade/Device Name: Biowy PlCC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: April 16, 2018 Received: April 17, 2018
Dear Andre Muller:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173956
Device Name Biowy PICC Catheter
Indications for Use (Describe)
The Biowy PICC catheter 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.
| 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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K173956 510(k) Summary
1. Submitter Information
| Submitter Name:Address: | Biowy Corporation27031/27002 Vista TerraceLake Forest, CA 92630Telephone No. 1-(949) 305-8211Fax Number: 1-(866) 506-5094 | |
|---|---|---|
| Primary Contact: | Andre von MullerRA/QA ManagerEmail: Avonmuller@biowy.com | |
| Date of Preparation: | December 20, 2017 | |
| 2. Device Information | ||
| Device NameTrade Name: | Biowy PICC CatheterBiowy PICC Catheter | |
| Common/Usual Name:Regulation NumberRegulation Name:Regulatory Class:Product Code:Classification Panel: | Peripherally Inserted Central Catheter (PICC)21 CFR 880.5970Percutaneous, implanted, long-term intravascular catheterIILJSGeneral Hospital |
3. Predicate Device:
| Device Name: | 5Fr DL PowerPICC® Catheter |
|---|---|
| Trade Name: | 5Fr DL PowerPICC® Catheter |
| Premarket Notification: | K051672 |
| Common/Usual Name | Peripherally Inserted Central Catheter (PICC) |
| Regulation Number | 21 CFR 880.5970 |
| Regulation Name: | Percutaneous, implanted, long-term intravascular catheter |
| Regulatory Class: | II |
| Product Code: | LJS |
| Classification Panel: | General Hospital |
4. Device Description:
The Biowy PICC catheters are opened-ended radiopaque polyurethane 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.
5. Indications for Use
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| SUBJECT (K173956) | PREDICATE (K051672) |
|---|---|
| Indications for Use | Indications for Use |
| The Biowy PICC catheter is indicated for short or long termperipheral access to the central venous system for intravenoustherapy and power injection of contrast media. For bloodsampling, infusion or therapy, use 4 French or larger catheter.The maximum recommended infusion rate is 5ml/sec for powerinjection of contrast media. The maximum pressure of powerinjectors used with the Biowy catheter may not exceed 300psi. | Identical to the FDA cleared510(k) Indications for Use |
6. Technological Comparison to Predicate
| Element Comparison | Subject DeviceK173956 | PredicateK051672 |
|---|---|---|
| Mode of operation | Power Injection | Same |
| Size | 5F and 4F | 5F |
| Priming volume | 4F (0.6ml), 5F (purple lumen 0.6ml, redlumen 0.6 ml) | 0.57 ml |
| Length | 60cm (5F), 55cm (4F) | 55cm |
| Lumens | Dual (5F), Single (4F) | Dual |
| Distal end configuration | Oval (5F), Round (4F) | Oval |
| Intended anatomic location of distal end | lower 1/3 of Superior Vena Cava | Same |
| Proximal end configuration | Oval (5F), Round (4F) Reverse taperdesign | Oval (5F) Reverse taperdesign |
| Gravity water flow rate (ml/h) | 695ml/h (5F) 434ml/h(4F) | 578 ml/h |
| Power Injection 10x | Meet design requirement | N/A* |
| Burst pressure | 267psi (5F), 278psi (4F) | 223 psi |
| Biocompatibility (See list below) | Biocompatible | Same |
| Primary Device Materials | Polyurethane and barium sulfate | Same |
| Radiopacity | Detectable | Same |
*Power Injection 10x: The subject device is additionally evaluated for worst-case scenario of 10x power injection. This difference of the power injection, flow rate and the burst pressure do not raise issues of safety and efficacy because the subject device is examined using the same ISO 1055-1 standard testing requirement as the predicate. The results fall within the limits allowed in the standard (ISO 10555-1).
The subject device (single lumen 4F and dual lumen 5F) are examined using the same testing requirements as the predicate. Therefore, the configuration difference does not raise issues of safety and efficacy.
The comparison above shows substantial equivalence of the subject device and the predicate.
7. Summary of Performance Tests
- . 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 is substantially equivalent to the predicate 5 Fr DL PowerPICC catheter and the risk associated with use of the new device have been adequately mitigated.
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The performance tests are listed below to demonstrate substantial equivalence of the subject device K173956 (4F SL and 5F DL), and applicable standards.
| Test | Standards | Results |
|---|---|---|
| Critical Dimensions | ISO 9626:2015 | Passed and met requirement |
| Priming Volume | Internal | Passed and met requirement |
| Tensile Force | ISO 10555-1:2014 | Passed and met requirement |
| Elongation and Stiffness | Internal | Passed and met requirement |
| Flexural Fatigue | Internal | Passed and met requirement |
| Aspiration Flow/ Catheter collapse | Internal | Passed and met requirement |
| Air Leakage during Aspiration | ISO 10555-1:2014 | Passed and met requirement |
| Gravity Flow | ISO 10555-1:2014 | Passed and met requirement |
| Pump Flow | ISO 10555-1:2014 | Passed and met requirement |
| Power Injection and Leak Testing | ISO 10555-1:2014 | Passed and met requirement |
| Burst Pressure | ISO 10555-1:2014 | Passed and met requirement |
| Power Injection/Burst Pressure | ISO 10555-1:2014 | Passed and met requirement |
| Power Injection (10x)/ Burst Pressure | ISO 10555-1:2014 | Passed and met requirement |
| Printing Marking | ISO 10555-3:2013 | Passed and met requirement |
| 6% Luer Taper | ISO 594-1:1986 | Passed and met requirement |
| Luer | ISO 594-1:1986ISO 594-2:1998 | Passed and met requirement |
| Luer Color Orientation | Internal | Passed and met requirement |
| Radiopacity | ASTM F640-12 | Passed and met requirement |
| List of Biocompatibility Tests: | ||
| • Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| • Sensitization | ISO 10993-10 | Non-sensitizer |
| • Irritation | ISO 10993-10 | Non-irritant |
| • Acute Systemic Injection | ISO 10993-11 | Non-toxic |
| • Material Mediated Pyrogen | USP<151> | Non-pyrogenic |
| • LAL (Bacterial Endotoxins) | USP <85>, <161> | Passed and met requirements |
| • Hemolysis (extract) | ISO 10993-4 | Non-hemolytic |
| • Hemolysis (direct) | ISO 10993-4 | Non-hemolytic |
| • Complement ActivationPredicate: PowerPICC®Catheter | ISO 10993-4 | Similar when compared to predicate |
| • Partial Thromboplastin Time(PTT) Predicate: PowerPICC®Catheter | ISO 10993-4 | Minimal activator (same as predicate) |
| • Dog Thrombogenicity | ISO 10993-4 | Similar to control |
| • Implantation | ISO 10993-6 | Non-irritant |
| • Subacute/sub Chronic Toxicity,Genotoxicity, Chronic Toxicity,and Carcinogenicity | ISO 10993-17ISO 10993-18 | Passed and met requirement |
| EtO sterilization | ISO 11135: 2014 | Met 10-6 SAL requirement |
| Clinical Evaluation | Internal | Passed |
| Accelerated Aging1.5 year (4F SL, 5F DL)3.0 year (4F SL, 5F DL) | ISO 11607-1:2006ASTM F88/F88M-15ISO 10555-1:2014 | Passed and met requirement |
Brief discussion of the non-clinical tests submitted for a determination of substantial equivalence:
Biowy has provided Performance Testing.
The Biowy PICC Catheters are designed, and made of the same polymer materials, use similar technological manufacturing methods, and have the same intended use as the predicate devices (PowerPICC Catheters).
Differences in technological characteristics (including flow rate, burst pressure, lumens, and the distal end configurations) of the device compared to the predicate do not raise different questions of safety and effectiveness.
Biowy has evaluated the differences using the same test requirements as the predicate device. The subject devices are substantially equivalent to the predicate device in specifications comparison.
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8. Conclusion
The Biowy PICC catheters (Model number PICC4SK and PICC5DK) has similar indications or use, technological characteristics and they meet all the predetermined performance acceptance criteria of the testing performed. Therefore, the devices are substantially equivalent to the predicate device the C.R. Bard 5 Fr DL PowerPICC® catheter, K051672.
§ 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.”