(58 days)
Not Found
No
The description focuses on a mechanical biopsy needle and its physical characteristics and performance, with no mention of AI or ML.
No
The device is described as an "Automatic Cutting Needle" intended for "obtaining biopsies," which is a diagnostic procedure, not a therapeutic one. It collects samples for "histological examination" to diagnose conditions.
No
Explanation: The device is used for obtaining biopsies, which is a procedure to collect tissue samples. While these samples may subsequently be used for diagnostic purposes, the device itself is a tool for sample acquisition, not for analyzing or interpreting the samples or producing a diagnosis.
No
The device description clearly describes a physical needle used for obtaining biopsies, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. The key is that the diagnostic process happens outside the body ("in vitro").
- Device Function: The Remington Medical Inc. Automatic Cutting Needle (NAC) is a device used to obtain a tissue sample from the body. It is a tool for collecting the specimen, not for analyzing it or performing a diagnostic test on it.
- Intended Use: The intended use is "for use in obtaining biopsies from soft tissues." This describes a sample collection procedure, not a diagnostic test performed on the sample.
- Device Description: The description reinforces that it's a tool for "obtaining biopsies," which are tissue samples.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or testing on the collected tissue sample. The sample is obtained for "histological examination," which is a separate process performed after the sample is collected, typically in a laboratory.
Therefore, the Remington Medical Inc. Automatic Cutting Needle (NAC) is a surgical instrument used for tissue collection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Remington Medical, Inc. Automatic Cutting Needle (NAC) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue turnors. It is not intended for use in bone.
Product codes
KNW
Device Description
The Remington Medical Inc. Automatic Cutting Needle (NAC) is a device used for obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors in combination with compatible commercial biopsy instrument(s)/gun(s) which are FDA cleared and distributed in the US Market. The Automatic Cutting Needles (NAC) are available in five qauges (differentiated by color) and seven needle lengths. The Automatic Cutting Needle (NAC) is advanced via the compatible commercial biopsy instrument/gun into the desired tissue to obtain a sample for histological examination. The Automatic Cutting Needle (NAC) is a sterile, single patient use and non-pyrogenic device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate that the subject device Remington Medical Inc. Automatic Cutting Needle (NAC) is as safe and as effective as the predicate device Bard® Biopty-Cut® Biopsy Needle, materials, technological characteristics and performance criteria were evaluated. The following tests were performed on the subject device
- Dimensional Requirements
- Stylet / Cannula to Hub Tensile Strength
- Equipment Interface
- Integrity of the Sterile Barrier
- Biocompatibility
- Pyrogenicity
- Sterility Assurance
- Distribution Simulation
In addition, the following ex vivo tests were performed on the subject device and predicate device:
- Simulated Use Soft Tissue Sampling
No clinical testing was required.
The results of the non-clinical testing demonstrated that the subject device, Remington Medical Inc. Automatic Cutting Needle (NAC), is substantially equivalent to the predicate device, Bard® Biopty-Cut® Biopsy Needle, with respect to intended use, materials, design, and technological characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains 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.
July 12, 2019
Remington Medical, Inc. Caitlin Senter Regulatory Affairs Manager 6830 Meadowridge Court Alpharetta, Georgia 30005
Re: K191315
Trade/Device Name: Remington Medical, Inc. Automatic Cutting Needle (NAC) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: May 14, 2019 Received: May 15, 2019
Dear Caitlin Senter:
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
1
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) 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 (QS) 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 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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Remington Medical Inc. Automatic Cutting Needle (NAC)
Indications for Use (Describe)
Remington Medical, Inc. Automatic Cutting Needle (NAC) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue turnors. It is not intended for use in bone.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image contains the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" on the right. The word "Remington" is in a larger, bold font, while the word "MEDICAL" is in a smaller font below it. The geometric shape is a stylized cross or plus sign with radiating lines.
Traditional 510(k) Notification Remington Medical Inc. Automatic Cutting Needle (NAC)
Section 5 - 510(k) Summary
| Preparation Date | May 14, 2019 |
|---|---|
| Applicant | Remington Medical, Inc. |
| 6830 Meadowridge Court, | |
| Alpharetta, GA, USA 30005 |
|
| | Registration Number: 1056553
Owner/Operator Number: 9006473 |
| Contact Person | Caitlin Senter, MS, RAC
Regulatory Affairs Manager
470-719-1105
caitlins@remmed.com |
| Trade Proprietary
Name(s) | Remington Medical, Inc. Automatic Cutting Needle (NAC) |
| Common Name (s) | Instrument, Biopsy |
| Classification Name | 21 CFR 876.1075 Gastroenterology-urology biopsy instrument
Product Code: KNW |
| Device Class: | II |
Predicate Device:
Bard® Biopty-Cut® Biopsy Needle (K962077)
Description of the Device:
The Remington Medical Inc. Automatic Cutting Needle (NAC) is a device used for obtaining biopsies from soft tissues such as liver, kidnev, prostate, spleen, lymph nodes and various soft tissue tumors in combination with compatible commercial biopsy instrument(s)/gun(s) which are FDA cleared and distributed in the US Market. The Automatic Cutting Needles (NAC) are available in five qauges (differentiated by color) and seven needle lengths. The Automatic Cutting Needle (NAC) is advanced via the compatible commercial biopsy instrument/gun into the desired tissue to obtain a sample for histological examination. The Automatic Cutting Needle (NAC) is a sterile, single patient use and non-pyrogenic device.
Intended Use/Indications for Use
Remington Medical, Inc. Automatic Cutting Needle (NAC) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Comparison to Predicate Device:
The technological characteristics (design, specifications, materials and performance) of the subject device and the predicate device are substantially equivalent.
4
Image /page/4/Picture/0 description: The image contains the logo for Remington Medical. The logo consists of a blue, stylized cross-like symbol on the left, followed by the text "Remington" in bold, dark blue letters. Below "Remington" is the word "MEDICAL" in smaller, lighter blue letters. The overall design is clean and professional, suggesting a healthcare or medical services company.
Traditional 510(k) Notification Remington Medical Inc. Automatic Cutting Needle (NAC)
| Subject Device: | Predicate Device: | |||||
|---|---|---|---|---|---|---|
| Remington Medical, Inc. Automatic Cutting | Bard® Biopty-Cut® Biopsy Needle | |||||
| Needle (NAC) | (K962077). | |||||
| Device Class | Class II | Class II | ||||
| FDA Product Code | KNW | KNW | ||||
| Requlation | 21 CFR 876.1075 (Instrument, Biopsy) | 21 CFR 876.1075 (Instrument, Biopsy) | ||||
| Indications for Use | Remington Medical, Inc. Automatic Cutting | The device is intended for use in obtaining | ||||
| Statement | Needle (NAC) is intended for use in obtaining | biopsies from soft tissues such as liver, | ||||
| biopsies from soft tissues such as liver, kidney, | kidney, prostate, spleen, lymph nodes and | |||||
| prostate, spleen, lymph nodes and various soft | various soft tissue tumors. It is not intended | |||||
| tissue tumors. It is not intended for use in bone. | for use in bone. | |||||
| Type of Use | Prescription Use | Prescription Use | ||||
| Cannula Material | Metal, Stainless Steel | Metal, Stainless Steel | ||||
| Cannula Depth | ||||||
| Marking | Wide Band, Centimeter Gradations | Wide Band, Centimeter Gradations | ||||
| (Optional) | ||||||
| Etched Tip | Standard | Optional | ||||
| Cannula Hub | ||||||
| Material | Color-coded Plastic (Polycarbonate) or | |||||
| Color-coded Plastic (Acrylonitrile butadiene | ||||||
| styrene (ABS)) | Color-coded Plastic (Polycarbonate) | |||||
| Stylet Material | Metal, Stainless Steel | Metal, Stainless Steel | ||||
| Stylet Hub Material | Color-coded Plastic (Polycarbonate) or | |||||
| Color-coded Plastic (Acrylonitrile butadiene | ||||||
| styrene (ABS)) | Color-coded Plastic (Polycarbonate) | |||||
| 12 GA | 10, 13, 16, 20 | Pale Blue* | 12 GA | 10, 16, 20 | Blue* | |
| Gauge/Length | 14 GA | 10, 12, 13, 16, 20 | Pale Green* | 14 GA | 10, 16, 20 | Green |
| (centimeters)/Color | 16 GA | 10, 13, 16, 20, 25 | White* | 16 GA | 10, 16, 20, 25, 30 | Purple |
| Depiction | 18 GA | 10, 13, 16, 20, 25, 30 | Pink* | 18 GA | 10, 16, 20, 25, 30 | Pink |
| 20 GA | 10, 13, 16, 20 | Yellow* | 20 GA | 10, 16, 20 | Yellow | |
| *Per ISO 6009:2016(E) | *Assumption per ISO 6009:2016(E) | |||||
| Mechanism of | ||||||
| Action | Single puncture and sample | Single puncture and sample | ||||
| Principle of | ||||||
| Operation | Cutting | Cutting | ||||
| Final Needle | ||||||
| Assembly | ||||||
| Protection | Sheath | Sheath | ||||
| Sterilization Method | ETO | ETO |
Performance Data:
To demonstrate that the subject device Remington Medical Inc. Automatic Cutting Needle (NAC) is as safe and as effective as the predicate device Bard® Biopty-Cut® Biopsy Needle, materials, technological characteristics and performance criteria were evaluated. The following tests were performed on the subject device
- Dimensional Requirements ●
5
Image /page/5/Picture/2 description: The image contains the logo for Remington Medical. The logo consists of a blue symbol on the left and the words "Remington MEDICAL" on the right. The symbol is a stylized blue shape with lines radiating outward from the center. The word "Remington" is in a bold, sans-serif font, and the word "MEDICAL" is in a smaller font below it.
Traditional 510(k) Notification Remington Medical Inc. Automatic Cutting Needle (NAC)
- Stylet / Cannula to Hub Tensile Strength ●
- Equipment Interface o
- Integrity of the Sterile Barrier ●
- Biocompatibility ●
- Pyrogenicity
- Sterility Assurance ●
- Distribution Simulation
In addition, the following ex vivo tests were performed on the subject device and predicate device:
- Simulated Use Soft Tissue Sampling ●
Clinical testing:
No clinical testing was required.
Conclusion:
The results of the non-clinical testing demonstrated that the subject device, Remington Medical Inc. Automatic Cutting Needle (NAC), is substantially equivalent to the predicate device, Bard® Biopty-Cut® Biopsy Needle, with respect to intended use, materials, design, and technological characteristics.