(117 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a biopsy needle, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is designed for obtaining biopsy samples, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device is used to obtain biopsy samples, which are then analyzed to diagnose a condition. The device itself is a tool for sample collection, not for diagnosis.
No
The device description clearly outlines physical components made of stainless steel and other materials, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain biopsy samples from soft tissue for percutaneous or open surgical procedures. This is a procedure performed on the patient's body to collect a sample.
- Device Description: The device is a needle designed for physically extracting tissue.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples outside of the body (in vitro). IVD devices are used to examine specimens such as blood, urine, or tissue samples in a laboratory setting to diagnose diseases or conditions.
The device is a tool for collecting a sample, not for performing diagnostic tests on that sample. The collected sample would then likely be sent to a laboratory for in vitro diagnostic testing, but the needle itself is not the IVD device.
N/A
Intended Use / Indications for Use
Spectra Soft Tissue Biopsy Needles are indicated for obtaining biopsy samples from soft tissue in percutaneous or open surgical procedures from various tissues through a combination of cutting and/or aspirating in such a manner that the biopsy sample is retained in the orifice of the needle.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Spectra Soft Tissue and Aspiration Biopsy Needles consist of a stainless steel needle and a translucent standard female Luer locking hub. A stylet rod assembly mates with the needle hub assembly. A depth stop is integral with each needle type to facilitate depth placement. The needle assembly is covered by a translucent removable needle guard. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. Needles are available with an echogenic treatment to help ensure strong reflection during ultrasound procedures.
Spectra Soft Tissue Biopsy Needles will be marketed as sterile, non-pyrogenic, and single use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound procedures
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the cap was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995. The submission device and predicate devices are identical. The battery of tests included the following:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Systemic Toxicity
- Hemocompatibility
Other performance tests
Physical tests were performed to ensure that the Spectra Soft Tissue Biopsy Needles had standard ISO Luer hubs with applicable luer testing using ISO 594. Needle bond strength tests with hubs were also conducted. The Spectra Soft Tissue Biopsy Needles passed all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Manan Soft Tissue Biopsy Needles K980122, Quick-Core™ Biopsy Needle K973565
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
Spectra Medical Devices Mr. Agustin Turriza Operations Manager 260-F/H Fordham Road Wilmington, Massachusetts 01887
Re: K142791
Trade/Device Name: Spectra Soft Tissue Biopsy Needles Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: October 21, 2014 Received: October 23, 2014
Dear Mr. Turriza:
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.
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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Premarket Notification Submission: SPECTRA SOFT TISSUE BIOPSY NEEDLES
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | ||
|---|---|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 | ||
| Indications for Use | See PRA Statement below. | ||
| 510(k) Number (if known) | |||
| K142791 | |||
| Device Name | |||
| Spectra Medical Devices, Inc. | |||
| Indications for Use (Describe) | |||
| Device Name: Spectra Soft Tissue Biopsy Needles: | |||
| Chiba Soft Tissue Biopsy Needle / Fine Needle Aspiration Biopsy Needle | |||
| Franseen Soft Tissue Biopsy Needle | |||
| Westcott Soft Tissue Biopsy Needle | |||
| Turner Soft Tissue Biopsy Needle | |||
| Greene Soft Tissue Biopsy Needle | |||
| Indications For Use: | |||
| Spectra Soft Tissue Biopsy Needles are indicated for obtaining biopsy samples from soft tissue in percutancous or open | |||
| surgical procedures from various tissues through a combination of cutting in such a manner that the | |||
| biopsy sample is retained in the orifice of the needle. | |||
| 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) | ||
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||
| FOR FDA USE ONLY | |||
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |||
| 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." | |||
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
(21 CFR 807.92) for Spectra Soft Tissue Biopsy Needles
SUBMITTER:
Spectra Medical Devices, Inc. 260-F/H Fordham Road Wilmington, Massachusetts, 01887
ESTABLISHMENT REGISTRATION NUMBER:
1224960
CONTACT:
Agustin Turriza Manager, Operations Telephone: (978) 657-0889 Fax: (978) 657-4339 Email: aturriza@SpectraMedical.com
DATE PREPARED:
Trade Name:
September 23, 2014
SUBMISSION DEVICE:
Spectra Soft Tissue Biopsy Needles
Regulation Name: Common/Usual Name: Classification Panel: Review Advisory Committee: Regulatory Class: Product Code: Regulation Number:
Gastroenterology-urology biopsy instrument Soft Tissue and Fine Needle Biopsy Needles Gastroenterology/Urology General & Plastic Surgery Class II KNW 21 CFR § 876.1075
The following predicate devices have not been the subject of a design related recall. No reference devices were used in this submission.
PREDICATE DEVICE:
| Trade Name: | Manan Soft Tissue Biopsy Needles K980122 |
|---|---|
| Regulation Name: | Gastroenterology-urology biopsy instrument |
| Common/Usual Name: | Manual biopsy needles for soft tissues |
| Classification Panel: | Gastroenterology/Urology |
| Review Advisory Committee: | General & Plastic Surgery |
| Regulatory Class: | Class II |
| Product Code: | KNW |
| Regulation Number: | 21 CFR § 876.1075 |
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| Trade Name: | Quick-Core™ Biopsy Needle K973565 |
|---|---|
| Regulation Name: | Gastroenterology-urology biopsy instrument |
| Common/Usual Name: | Soft Tissue Biopsy, puncture and aspiration cannulas and needles |
| Review Advisory Committee: | General & Plastic Surgery |
| Regulatory Class: | Class II |
| Product Code: | KNW |
| Regulation Number: | 21 CFR § 876.1075 |
DEVICE DESCRIPTION:
The Spectra Soft Tissue and Aspiration Biopsy Needles consist of a stainless steel needle and a translucent standard female Luer locking hub. A stylet rod assembly mates with the needle hub assembly. A depth stop is integral with each needle type to facilitate depth placement. The needle assembly is covered by a translucent removable needle guard. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. Needles are available with an echogenic treatment to help ensure strong reflection during ultrasound procedures.
Spectra Soft Tissue Biopsy Needles will be marketed as sterile, non-pyrogenic, and single use devices.
INTENDED USE:
The Spectra Soft Tissue Biopsy Needles are intended to be used by medical professionals to obtain biopsy samples from soft tissue in percutaneous or open surgical procedures from various tissues through a combination of cutting and/or aspirating in such a manner that the biopsy sample is retained in the orifice of the needle.
INDICATIONS FOR USE:
Chiba Soft Tissue Biopsy Needle / Fine Needle Aspiration Biopsy Needle Device Name: Franseen Soft Tissue Biopsy Needle Greene Soft Tissue Biopsy Needle Turner Soft Tissue Biopsy Needle Westcott Soft Tissue Biopsy Needle
The Spectra Soft Tissue Biopsy Needles are indicated for obtaining biopsy samples from soft tissue in percutaneous or open surgical procedures from various tissues through a combination of cutting and/or aspirating in such a manner that the biopsy sample is retained in the orifice of the needle.
The Indications for Use statement for the Spectra Soft Tissue Biopsy Needles is not identical to those of the predicate devices; however, the differences do not alter the intended use of the device nor do they affect the safety and efficacy of the device relative to the predicate. Both the submission and predicate devices have the same intended use.
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TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
The Spectra Soft Tissue Biopsy Needles utilize substantially equivalent technological elements compared to the predicate devices used in this submission:
- the Spectra Soft Tissue Biopsy Needles are manual soft tissue biopsy needles
- they use substantially equivalent materials
- they are sterilized using ethylene oxide
- same fundamental design: plastic injection molded hub, a stainless steel stylet secured in a ● stylet, a stainless steel cannula, echogenic options, industry-standard grinding and bevel designs
- same method of operation
- no change in patient population
- no change in clinical context
- no change in intended use ●
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the cap was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995. The submission device and predicate devices are identical. The battery of tests included the following:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Systemic Toxicity ●
- Hemocompatibility
Other performance tests
Physical tests were performed to ensure that the Spectra Soft Tissue Biopsy Needles had standard ISO Luer hubs with applicable luer testing using ISO 594. Needle bond strength tests with hubs were also conducted. The Spectra Soft Tissue Biopsy Needles passed all tests.
CONCLUSION
The Submission Devices, Spectra Soft Tissue Biopsy Needles, have met all established acceptance criteria for performance testing. The Submission Device is substantially equivalent to the predicate device in terms of intended use, design, materials, operation, function, and sterilization method. This demonstrates that the Submission Devices are safe and effective for the intended use, and based on FDA's 510(k) Decision-Making Flowchart is substantially equivalent to the indicated Predicate Devices: