(57 days)
The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices. The Introducer Sheath is composed of the Guiding Sheath and the Dilator. The Introducer Sheath is available in multiple effective lengths and curve shape configurations.
This document is an FDA 510(k) premarket notification letter for an "Introducer Sheath" device, which is a Class II medical device. The letter determines substantial equivalence to a legally marketed predicate device.
The provided document does NOT describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-powered device or a study involving human readers. Instead, it details the non-clinical bench performance testing for a physical catheter introducer sheath.
Therefore, many of the requested information points, such as AI-specific acceptance criteria, human reader studies, or ground truth establishment for a training set, are not applicable to this document.
However, I can extract the information that is relevant to the physical device performance testing.
Here's an analysis of the provided information:
This document describes the regulatory approval of a physical medical device (an Introducer Sheath), not an AI/Software as a Medical Device (SaMD) or a study involving diagnostic image analysis.
As such, the information requested regarding AI acceptance criteria, human reader studies (MRMC), standalone algorithm performance, ground truth for AI, and training/test set sample sizes for AI is not present in this document. The document focuses on the mechanical, material, and sterility performance of a physical device.
Information relevant to the physical device's performance testing:
1. A table of acceptance criteria and the reported device performance
The document states: "Performance tests were conducted to ensure that the Introducer Sheath met the applicable design and performance requirements throughout its shelf life." and "The tests results indicate that the Introducer Sheath passed all the tests and it conforms to 150 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires."
Explicit Acceptance Criteria (implied by passing tests and conformity to standards):
| Performance Aspect | Acceptance Criteria (Implied by conformity to ISO 11070:2014 and passing "all tests") | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Dilator Appearance | Conforms to visual inspection | Passed |
| Dilator Dimensional (OD/ID, working length) | Within specified tolerances | Passed |
| Dilator Luer compatibility | Compatible with Luer fittings | Passed |
| Dilator Guidewire compatibility | Compatible with guidewires | Passed |
| Dilator Tensile strength | Meets strength requirements | Passed |
| Sheath Appearance | Conforms to visual inspection | Passed |
| Sheath Dimensional (OD/ID, working length, curve geometry) | Within specified tolerances | Passed |
| Sheath Luer compatibility | Compatible with Luer fittings | Passed |
| Sheath Guidewire compatibility | Compatible with guidewires | Passed |
| Valve liquid/air leak test | No significant leakage | Passed |
| Sheath Tensile strength | Meets strength requirements | Passed |
| Sheath Torque strength | Meets torque requirements | Passed |
| Sheath Simulated use | Functions as intended in simulated environment | Passed |
| Sheath Kink resistance | Resists kinking | Passed |
| Particulate matter | Meets particulate matter limits | Passed |
| Radiopacity | Visible under fluoroscopy | Passed |
| Biocompatibility | ||
| Cytotoxicity | Non-toxic to cells (per ISO 10993-1) | Passed |
| Sensitization | Not a sensitizer (per ISO 10993-1) | Passed |
| Irritation | Non-irritating (per ISO 10993-1) | Passed |
| Acute Systemic & Pyrogenicity | No acute systemic toxicity and non-pyrogenic (per ISO 10993-1) | Passed |
| Hemocompatibility | Biocompatible with blood (per ISO 10993-1) | Passed |
| Sterilization | ||
| Sterility Assurance Level (SAL) | 10^-6 (per ISO 11135:2014 via overkill half-cycle) | Achieved |
| Residual EO/ECH | Do not exceed average daily dose of 4 mg (EO) / 9 mg (ECH) per ISO 10993-7:2008 (after 24h aeration) | Met |
| Shelf-Life | Maintained performance for 24 months | Confirmed for 24 months |
| Packaging & Transport | Integrity maintained | Passed |
| Labeling/Identification | Conforms to requirements | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Performance tests" and "tests results" but does not specify the sample sizes (e.g., number of units tested for each physical property) or the provenance (country of origin, retrospective/prospective) of the data. This is typically detailed in the full test reports that support the 510(k) submission, but not in the summary letter itself.
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. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for a physical device, not an AI diagnostic tool or an imaging study requiring expert adjudication.
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. This is for a physical device. Clinical studies (including MRMC) were explicitly not included: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device, the "ground truth" is defined by established engineering and material science standards (e.g., ISO 11070:2014, ISO 10993 series for biocompatibility) and internal design specifications. There isn't "ground truth" in the diagnostic sense (like pathology for AI).
8. The sample size for the training set
Not applicable. This is for a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is for a physical device, not an AI model.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
November 8, 2024
Pulnovo Medical (Wuxi) Co., Ltd Wen Gu Clinical Vice President 3rd Floor, Bldg D 17, No. 1719-17 Huishan Ave, & 3rd Floor, Bldg D 11, No. 1719-11 Huishan Ave, Huishan Economic Dev Zone Wuxi, Jiangsu 214000 China
Re: K242756
Trade/Device Name: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090. PFlexi45L065. PFlexi45L070. PFlexi45L075. PFlexi45L080. PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: September 12, 2024 Received: September 12, 2024
Dear Wen Gu:
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 (the 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 available 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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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
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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, Sevan R. 2024.11.08 Oungoulian -S 16:59:04 -05'00' For Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular 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) K242756
Device Name
Introducer Sheath (PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075. PFlexi30L080. PFlexi45L065. PFlexi45L070. PFlexi45L075. PFlexi45L080. PFlexi45L090. PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090
Indications for Use (Describe)
The Introducer Sheath is intended for the introduction of diagnostic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
| 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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Summary
I Submitter
Prepared by:
Ms. Anlan Zhang APlus Healthcare Technology (Shanghai) Co., Ltd. E-mail: anlan.zhang@ap-healthcare.com
Prepared for:
Pulnovo Medical (Wuxi) Co., Ltd.
3rd Floor, Building D 17, No. 1719-17 Huishan Avenue, and 3rd Floor, Building D 11, No. 1719-11, Huishan Avenue, Huishan Economic Development Zone, Wuxi, 214000 Jiangsu Province, China
Contact person:
Name: Mr. Wen Gu Occupation title: Clinical Vice President Tel.: +86-18906178526 E-mail: ra@pulnovomed.com
Preparation date: September 12, 2024
II Proposed Device
| Trade Name of Device: | Introducer Sheath |
|---|---|
| Models: | PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090 |
| Regulation name: | Catheter introducer |
| Regulation Number: | 21 CFR 870.1340 |
| Regulatory Class: | Class II |
| Product code: | DYB |
| Review Panel | Cardiovascular |
III Predicate Device
Predicate device
510(k) Number: K210627 Product Code: DYB
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Classification: 21 CFR 870.1340 Trade Name: Breezeway II Regulatory Class: II
Reference Device 510(k) Number: K172995 Product Code: DYB Classification: 21 CFR 870.1340 Trade Name: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Regulatory Class: II
IV Device description
The Introducer Sheath is intended for establishing a percutaneous access that facilitates the introduction of intravascular devices. The Introducer Sheath is composed of the Guiding Sheath and the Dilator. The Introducer Sheath is available in multiple effective lengths and curve shape configurations.
Principles of Operation
The Introducer Sheath is used to assist in the insertion of diagnostic/therapeutic instruments such as guide wires, catheters, and other medical devices into blood vessels, or to establish percutaneous access pathways that facilitate the insertion of intravascular instruments.
V Indications for use
The Introducer Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements.
Do not use this device for neural placements.
VI Comparison of technological characteristics with the predicate device
The comparable properties between the proposed device and the predicate devices are listed in Table 1. Table 1 compares the Introducer Sheath to the predicate devices with respect to intended use, technological characteristics, and principles of operations, providing more detailed information regarding the bases for the determination of substantial equivalence.
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| Items | Proposed Device | Predicate Device | Reference Device |
|---|---|---|---|
| Devicename | Introducer Sheath | Breezeway II | Destination®GuidingSheath (Carotid, Peripheraland Renal) |
| RegulatoryDecision | K210627 | K172995 | |
| ProductCode | DYB | DYB | DYB |
| RegulationNumber | 870.1340 | 870.1340 | 870.1340 |
| IntendedUse/Indications for use | The IntroducerSheath is intended forthe introduction ofdiagnostic andtherapeutic devicesinto the humanvasculature,including but notlimited tointracardiac, renal orother peripheralplacements.Do not use thisdevice for neuralplacements. | The Breezeway IIproducts are intended forthe introduction ofdiagnostic andtherapeutic devices intothe human vasculature,including but not limitedto intracardiac, renal orother peripheralplacements.Do not use this devicefor neural placements. | The Destination® CarotidGuiding Sheath is designedto be used for theintroduction of interventionaland diagnostic devices intothe human vasculature,including but not limited tothe carotid arteries.The Destination® PeripheralGuiding Sheath is designedto be used for theintroduction ofinterventional and diagnosticdevices into the humanvasculature, including butnot limited to lowerextremity access via acontralateral approach.The Destination® RenalGuiding Sheath is intendedfor the introduction ofinterventional and diagnosticdevices into the humanvasculature including butnot limited to |
| the renal arteries. | |||
| OperationPrinciple | Operated manuallyor by a manualprocess | Operated manually or bya manual process | Operated manually or by amanual process |
| Design /Construction | Sheath, Dilator,Hemostatic Valvewith side tube andthree-way stopcock | Sheath, Dilator,Hemostatic Valve withside tube and three-waystopcock | Sheath, Dilator, HemostaticValve with side tube andthree-way stopcock, andDilator Retaining Clip |
| Materials | Sheath AssemblyTubing: PTFE-SSLbraided-Pebax,BaSO4Tip: Pebax, BaSO4Hydrophilic Coating:NARadiopaque Band:Platinum-IridiumalloyDilator AssemblyTubing: HDPE,BaSO4Hub: HDPEHemostatic ValveAssemblyValve assembly:Nylon, siliconerubber, PolyurethaneSide Tube/3-WayStopcock Assembly:Polyvinyl chloride,Polycarbonate,Polyethylene | SheathLiner (Inner): PA12Distal Tip (Outer): Pebax45DProximal Shaft (Outer):Pebax 63DSheath Hub Cap:PolycarbonateSheath Coating:HydrophobicHemostatic Valve:SiliconeMarker Band: GoldDilator6F to 12F: HDPE (Bodyand Hub)14F: LDPE (Body),HDPE (Hub) | Sheath AssemblyTubing: PTFE-SSLcoil-NylonTip: NylonHydrophilic Coating:Polyvinylpyrrolidone-basedCoatingHub: NylonRadiopaque Band: GoldDilator Assembly |
| Valve assembly: | |||
| Polypropylene, | |||
| Polycarbonate, Silicone | |||
| Rubber, Elastomer, | |||
| Non-reactive silicone oil | |||
| 1000cst | |||
| Side Tube/3-Way Stopcock | |||
| Assembly: Same as TBV | |||
| Package | Unit Pouch | Unit Pouch | Unit Pouch |
| Shelf Box | Shelf Box | Shelf Box | |
| Shipping Carton | Shipping Carton | Shipping Carton | |
| Sheath Size: 9Fr | Sheath Size: 6Fr to 14 Fr | Sheath Size | |
| Sheath Length: | Sheath Length | Carotid: 6-7Fr | |
| 65-90cm | 79 cm (6Fr to 14 Fr) | Peripheral: 5-8Fr | |
| Hydrophilic Coating: | 110 cm (6Fr to 10Fr) | Renal: 5-7Fr | |
| NA | Hydrophilic Coating: | Sheath Length | |
| Curve Shapes: ST, | Hydrophobic | Carotid: 80-110cm | |
| MP | Curve Shapes: Not | Peripheral: 45-110cm | |
| Dilator Extended | reported | Renal: 45-55cm | |
| Length: 2.5cm | Hydrophilic Coating | ||
| Dilator Extended | Carotid Distal 15 cm | ||
| Specifications | Length: Not reported | Peripheral Distal 15-60 | |
| cm | |||
| Renal Distal 5 cm | |||
| Curve Shapes | |||
| Carotid: ST, MP | |||
| Peripheral: ST | |||
| Renal: ST, HS, MP, RDC, | |||
| LIMA | |||
| Dilator Extended Length | |||
| Carotid: 5cm | |||
| Peripheral: 2.5 and 5cm | |||
| Renal: 2cm | |||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf life | 24 months | 36 months | 6 months |
| DisposableSingle Use | Yes | Yes | Yes |
Table 1 Comparison of technological characteristics with the predicate device
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VII Performance Data
Non-Clinical Bench Performance Testing
Performance tests were conducted to ensure that the Introducer Sheath met the applicable design and performance requirements throughout its shelf life. The physical properties (including particulate matter), chemical properties, microbial properties, sterile barrier properties, biocompatibility, shelf-life, packaging, simulated transportation and labeling and identification of the Introducer Sheath products were tested to ensure the design output meets the requirements of the design inputs. The tests results indicate that the Introducer Sheath passed all the tests and it conforms to 150 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires. The basis for a determination of substantial equivalence of the device is demonstrated by the following:
Physical properties
- Dilator: 1.
- . Appearance,
- Dimensional (including OD/ID, working length), .
- Luer compatibility, ●
- Guidewire compatibility, .
- . Tensile strength.
Introducer sheath: 2.
- . Appearance,
- Dimensional (including OD/ID, working length, curve geometry), .
- Luer compatibility, .
- Guidewire compatibility. .
- Valve liquid/air leak test. ●
- Tensile strength, ●
- Torque strength, ●
- Simulated use,
- Kink resistance, .
- Particulate matter, .
- . Radiopacity.
Biocompatibility
The Introducer Sheath was evaluated for biological safety based on its body contact and duration per ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1.
The Introducer Sheath is classified as an Externally Communicating Medical Device with limited (<24 hours) direct contact with patients' circulating blood.
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The following tests are recommended by FDA and ISO 10993-1 to be performed for this device classification:
-
- Cytotoxicity
- Sensitization 4.
- ર. Irritation
- Acute Systemic & Pyrogenicity 6.
-
- Hemocompatibility
Sterilization
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The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.
Introducer Sheath is a limited exposure device. After 24 hours of heated aeration, the level of residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) do not exceed an average daily dose of 4 mg and 9 mg respectively per ISO 10993-7:2008.
VIII Clinical Testing
No clinical study is included in this submission.
IX Conclusion
Based on the similarity of the subject and predicate devices in terms of the intended use, principle of operation and overall technological characteristics, and the results of the conducted tests, the Pulnovo Medical (Wuxi) Co., Ltd. Introducer Sheath is substantially equivalent to the predicate device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).