(84 days)
Introducer for Endoscopic/Laparoscopic procedures.
The PMIPIN15 Percutaneous Introducer Needle is a single- use, disposable EO sterilized device made of 304 stainless steel with a luer hub made of polycarbonate. The introducer sheath is 5 Fr and manufactured from low density polyethylene. The device is manually inserted by the physician during endoscopic and/or laparoscopic procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PMIPIN15 Percutaneous Introducer Needle.
The document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive new clinical performance data. Therefore, the "acceptance criteria" here are largely derived from the performance and characteristics of the predicate device and relevant international standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission, the "acceptance criteria" are essentially demonstrating equivalence to the predicate device and compliance with relevant standards. The "device performance" is presented as meeting these standards and being similar to the predicate.
| Acceptance Criteria Category | Specific Acceptance Criterion (Implicitly derived or explicitly stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliant with ISO 10993 series for medical devices. | Passed Cytotoxicity Test (ISO10993-5), Dermal Sensitization Guinea Pig Maximization Tests (ISO10993-10), Intracutaneous Test (ISO10993-10). |
| Sterilization | Validated for Ethylene Oxide (EO) sterilization. | Passed Ethylene Oxide Sterilization Validation (ISO 11135:2014). |
| Packaging | Validated for package integrity and shelf-life. | Passed Package Validation (ASTM 2096-11, ASTM F1186/1886M-16, ASTM F88/F88M-15, ASTM D5276-98). |
| Physical/Mechanical Performance | Equivalent to predicate device in design and materials; compliant with ISO 11070:2014(E) for needle and hub strength, force at break, and penetration. | Physical measurements and visual inspection confirmed similarity to predicate. Performance evaluation (strength of union, force at break) met ISO 11070:2014(E). Needle penetration testing met ISO 11070:2014(E). |
| Accelerated Aging/Shelf Life | Validated for shelf life. | Passed Accelerated aging testing per ASTM F1980-16. Device "met its design specifications" for a 2-year shelf life. |
| Design Specifications | Meet established design specifications (e.g., needle gauge, length, introducer diameter, materials). | The device "met its design specifications" and shown to be similar to the predicate for all listed specifications. |
| Indications for Use | Same as predicate. | "Introducer for Endoscopic/Laparoscopic procedures." - Same as predicate. |
| Sterility | Must be sterile. | "Yes" (Sterility) - Same as predicate. |
| Single Use | Must be single use. | "Yes" (Single Use) - Same as predicate. |
| Biocompatible | Must be biocompatible. | "Yes" (Biocompatible) - Same as predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not provide specific sample sizes for the individual tests (biocompatibility, sterilization, package, mechanical performance). It states "A series of preclinical tests were performed" and refers to ISO and ASTM standards, which would dictate appropriate sample sizes for each test.
- Test Set Sample Size: Not explicitly stated (implied by compliance with standards).
- Data Provenance: The tests are non-clinical (laboratory-based, material-based). There's no human clinical data presented, so country of origin and retrospective/prospective distinctions are not applicable in the typical sense. Physical measurements and performance evaluations were done on samples of the new device and the predicate device. Needle penetration testing was conducted by an "independent lab."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device's evaluation is based on non-clinical engineering and materials testing, not on interpretation by clinical experts. The "ground truth" for these types of tests comes from the established scientific methods and standards (ISO, ASTM).
4. Adjudication Method for the Test Set
Not applicable. As described above, there is no clinical data or expert interpretation requiring adjudication. Performance is assessed against quantitative standards.
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 not an AI-powered diagnostic or assistive device. It is a physical percutaneous introducer needle.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- International Standards: ISO 10993 (biocompatibility), ISO 11135 (sterilization), ISO 11070 (needles), ASTM standards (packaging, shelf-life). These standards define acceptable methodologies and performance thresholds.
- Predicate Device Characteristics: For comparative aspects (design, materials, indications for use), the characteristics of the legally marketed predicate device (Ranfac Percutaneous Introducer PIN-15, K951090) serve as a de-facto "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
August 6, 2019
Progressive Medical, Inc. % David Mullis Regulatory Consultant Mullis & Associates, Inc. 367 Pleasant Valley Rd., P.O. Box 39 Good Hope, Georgia 30641
Re: K191295
Trade/Device Name: Percutaneous Introducer Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 30, 2019 Received: May 14, 2019
Dear David Mullis:
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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K191295
Device Name
PMIPIN15 Percutaneous Introducer Needle (5Fr)
Indications for Use (Describe)
Introducer for Endoscopic/Laparoscopic procedures.
| 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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Progressive Medical, Inc. PMIPIN15 Percutaneous Introducer Needle K191295
| 6.510(k) Summary | ||||
|---|---|---|---|---|
| Submitter: | Progressive Medical, Inc.997 Horan DriveFenton, MO 63026Establishment Registration Number: 300236238 | |||
| Contact: | David W. Mullis, Jr., Ph.D., RAC, FRAPSRegulatory ConsultantMullis & Associates, Inc.367 Pleasant Valley Rd., P.O. Box 39Good Hope, GA 30641Phone: 770-722-6413Fax:770-207-7682 | |||
| Submission Date: | April 30, 2019 | |||
| Trade Name: | PMIPIN15 Percutaneous Introducer Needle (5 Fr) | |||
| Common Name: | Introducer | |||
| Regulation: | 876.1500 | |||
| Classification: | Class II | |||
| Product Code: | GCI | |||
| Panel: | General & Plastic Surgery | |||
| Medical Specialty: | Gastroenterology/Urology | |||
| Predicate Devices: | Ranfac Percutaneous Introducer PIN-15, K951090 | |||
| Device Description: | The PMIPIN15 Percutaneous Introducer Needle is a single-use, disposable EO sterilized device made of 304 stainless steelwith a luer hub made of polycarbonate. The introducer sheathis 5 Fr and manufactured from low density polyethylene. Thedevice is manually inserted by the physician during endoscopicand/or laparoscopic procedures. | |||
| Indication for Use: | Introducer for Endoscopic/Laparoscopic procedures. | |||
| Substantial Equivalence: |
The PMIPIN15 Percutaneous Introducer Needle (5 Fr) is substantially equivalent to the Ranfac PIN-15 Introducer that is
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legally marketed in the United States. Each device has the same indication use and is manually inserted by the physician. Both devices have common design specifications and materials. The PMIPIN15 Percutaneous Introducer Needle is a single use, disposable, EO sterilized device made of 304 stainless steel with a luer hub made of polycarbonate. Its 5 Fr introducer sheath is manufactured from low density polyethylene which is the same material as its predicate. Both the PMIPIN15 and the PIN-15 have a protective sleeve made of low density polyethylene.
| Comparison |
|---|
| New Device | Predicate Device | Comment | |
|---|---|---|---|
| Product Name | PMIPIN15 (5 Fr) | Ranfac PIN-15 | |
| Percutaneous | Percutaneous | ||
| Introducer Needle | Introducer Needle | ||
| 510(k) Number | K191295 | K951090 | |
| Company | Progressive Medical, | Ranfac Corp. | |
| Inc. | |||
| Indication for Use | Introducer for | Introducer for | Same |
| Endoscopic/ | Endoscopic/ | ||
| Laparoscopic | Laparoscopic | ||
| procedures | procedures | ||
| Classification | Laparoscope, | Laparoscope, | Same |
| Name | General & Plastic | General & Plastic | |
| Surgery | Surgery | ||
| Common Name | Introducer Needle | Introducer | |
| Product Code | GCJ | GCJ | Same |
| Regulatory Class | Class II | Class II | Same |
| Regulation # | 876.1500 | 876.1500 | Same |
| Sterility | Yes | Yes | Same |
| Sterilization | EO | EO | Same |
| Method | |||
| Single Use | Yes | Yes | Same |
| Lengths/Sizes | Needle Gauge: 15 | Needle Gauge: 15 | Same |
| Needle Length: 116 | Needle Length: 116 | ||
| mm | mm | ||
| Introducer length: | Introducer length: | ||
| 104.4 mm | 104.4 mm | ||
| Introducer | Introducer | ||
| Diameter: 5 Fr | Diameter: 5Fr |
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| Materials | Needle: 304 | Needle: 304 | Same |
|---|---|---|---|
| Stainless Steel | Stainless Steel | ||
| Handle: Low | Handle: Low | ||
| Density | Density | ||
| Polyethylene | Polyethylene | ||
| Female Luer Hub: | Female Luer Hub: | ||
| Polycarbonate | Polycarbonate | ||
| Introducer: Low | Introducer: Low | ||
| Density | Density | ||
| Polyethylene | Polyethylene | ||
| Protective Sleeve: | Protective Sleeve: | ||
| Low Density | Low Density | ||
| Polyethylene | Polyethylene | ||
| Mode of Operation | Manual Insertion | Manual Insertion | Same |
| Package | Tyvek/Plastic Pouch | Tyvek/Plastic | Same |
| Biocompatible | Yes | Yes | Same |
| Shelf Life | 2 yr. | 5 Yr. | |
| Bioburden | Yes | Unknown |
Non-clinical Testing: A series of preclinical tests were performed to assess the safety and performance of the PMIPIN15 Percutaneous Introducer Needle (5Fr) including biocompatibility physical and mechanical performance.
The following biocompatibility and safety tests were conducted in compliance with ISO standards:
- Cytotoxicity Test: ISO10993-5 ●
- Dermal Sensitization Guinea Pig Maximization Tests: 1SO10993-10
- Intracutaneous Test: ISO10993-10
- Ethylene Oxide Sterilization Validation: ISO 11135:2014 ●
- Package Validation: ASTM 2096-11, ASTM ● F1186/1886M-16, ASTM F88/F88M-15, ASTM D5276-98
- Shelf Life Validation: ASTM F-1980-16
Physical measurements and visual inspection of the PMIPIN15 and Ranfac PIN-15 were performed to confirm similarity in design and materials. Performance evaluation, in compliance with ISO 11070:2014(E), was performed for strength of union of needle and hub as well as force at break. Needle penetration testing was conducted by an independent lab in accordance with ISO 11070:2014(E). Accelerated aging testing was conducted per ASTM F1980-16. Package integrity testing to assess seal strength and leak detection were performed in conformance with ASTM standards, as referenced above. The PMIPIN15 Percutaneous Introducer Needle (5 Fr) met its design specifications.
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Progressive Medical, Inc. PMIPIN15 Percutaneous Introducer Needle K191295
Based on preclinical testing results, indications for use, Conclusion: performance evaluation, design specifications, and comparison with the predicate device, the PMIPIN15 Percutaneous Introducer Needle (5Fr) is substantially equivalent to its referenced predicate.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.