(57 days)
The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.
The M-CORE disposable core biopsy needle is a sterile, disposable biopsy needle featuring stainless steel cutting cannula and stylet, with sample is a lotenio, disposable biopsy needle leading stames steaturing statiness steat themoplastic removable spacer is provided to allow easy insection of both hubs into a Bard@ Magnum® reusable biopsy instrument. An LDP of the county the neder in both huss in a Barde Magnum® reuseble available in gauges from 14 - 18 and lengths from 10 - 25 centimeters.
The provided 510(k) summary for the M-CORE disposable core biopsy needle does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria are met. The document focuses on demonstrating substantial equivalence to predicate devices based on design and materials, and mentions "Performance testing summary" but does not elaborate on the specific tests or their results within this summary.
Here's a breakdown of what can be extracted and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., biopsy sample quality scores, tensile strength, or cutting efficiency thresholds). Instead, it relies on demonstrating that the device is "substantially equivalent" to predicate devices, implying similar performance.
The summary states: "Performance testing confirms that the quality of the samples obtained with the M-CORE disposable core biopsy needle is substantially equivalent to the predicate device(s)." This is a general statement of performance, not a quantified measurement against an acceptance criterion.
The table provided in the document compares device characteristics, not performance metrics:
| Characteristic | Reported Device (M-CORE Needle) Performance (Implicitly equivalent to predicate) | Acceptance Criteria (Not explicitly stated in this document) |
|---|---|---|
| Cannula and Stylet Material | 304SS | (Implicitly: Same as predicate) |
| Cannula and Stylet Hub Material | Polycarbonate | (Implicitly: Same as predicate) |
| Sheath | LDPE | (Implicitly: Same as predicate) |
| Stylet Sample Notch | 19mm | (Implicitly: Same as predicate) |
| Spacer | Thermoplastic | (Implicitly: Same as predicate) |
| Non-Pyrogenic | Yes, LAL Test | Yes (Implicitly: Demonstrated by LAL Test) |
| Sterile Packaging | Tyvek pouch | (Implicitly: Same as predicate) |
| Sterilization Method | Gamma, 11137, VDMax25, SAL 10-6 Dose: 25 - 40 kGy | (Implicitly: Equivalent or superior to predicate's EO SAL 10-6 or Gamma) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any information regarding the sample size used for performance testing (e.g., number of biopsies performed, number of needles tested). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
No information is provided about experts used to establish ground truth. The summary mentions "the quality of the samples obtained," suggesting an evaluation of biopsy specimens, but does not detail how this quality was assessed or by whom.
4. Adjudication Method for the Test Set
No information is provided regarding any adjudication method for performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied. This device is a biopsy needle, not an imaging or diagnostic algorithm that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical instrument, not an algorithm.
7. Type of Ground Truth Used
While not explicitly called "ground truth," the performance testing likely involved assessing the "quality of samples obtained." This would typically be evaluated through:
* Histopathology/Pathology: Examination of the tissue samples by a pathologist to determine adequacy for diagnosis.
* Visual Inspection/Gross Examination: Assessment of the sample size, integrity, and appearance.
The document does not specify which of these, or any other method, was used.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
In summary, the provided 510(k) notification primarily focuses on demonstrating substantial equivalence through a comparison of design and materials with predicate devices, and a general statement about performance testing confirming sample quality. It lacks the specific details about acceptance criteria, study sizes, methodologies, and expert involvement that your detailed questions request. This level of detail is often found in the full test reports referenced (e.g., "See Section 18" for Performance Testing Summary), but not typically within the concise 510(k) summary itself.
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Insert Molding Solutions, Inc.
510(k) SUMMARY
Date of Preparation: 31 MAY 2011 JUL 2 9 2011
Company/Contact Information: Paul Hendrixson, President Insert Molding Solutions, Inc. 4325 Settingdown Circle, Suite 103 Cumming, GA 30028 Phone: 678-965-5334 Fax: 678-965-5343 Email: paul@insertmoldingsolutions.com Trade Name M-CORE disposable core biopsy needle Common Name Biopsy Needle
Classification Name Gastroenterology-urology biopsy instrument, needle (21CFR 876.1075, Product Code KNW) Name of Predicate(s) or Legally Marketed Device(s) K092059 - Riverpoint Medical RP Cutting Needle K883469 -C.R. Bard® Aspiration Biopsy System ("Magnum®") K994272- Promex MCN Automated Core Biopsy Device
Device Description
The M-CORE disposable core biopsy needle is a sterile, disposable biopsy needle featuring stainless steel cutting cannula and stylet, with sample is a lotenio, disposable biopsy needle leading stames steaturing statiness steat themoplastic removable spacer is provided to allow easy insection of both hubs into a Bard@ Magnum® reusable biopsy instrument. An LDP of the county the neder in both huss in a Barde Magnum® reuseble
available in gauges from 14 ... 18 and longthe forces the needle and packaging from available in gauges from 14 - 18 and lengths from 10 - 25 centimeters.
Indications for Use
The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft issues areas is nicences for as will the barde nagnums biopsy instrument in obtaining
The M-CORE needle is not intended for you in hans The M-CORE needle is not intended for use in bone
Substantial Equivalence
The M-CORE disposable biopsy needle has the same intended use as the predicate device(s) and has the same technological characteristics in terms of basic design and materials.
| Characteristic | RP Cutting Needle | Magnum Needle | MCN Needle | M-CORE Needle |
|---|---|---|---|---|
| Manufacturer | Riverpoint Medical | C.R. Bard | Promex | Insert MoldingSolutions |
| 510(k) Number | K092059 | K883469 | K994272 | |
| Cannula and Stylet Material | 304SS | 304SS | 304SS | 304SS |
| Cannula and Stylet HubMaterial | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate |
| Sheath | LDPE | LDPE | LDPE | LDPE |
| Stylet Sample Notch | 19mm | 19mm | 19mm | 19mm |
| Spacer | Thermoplastic | Thermoplastic | Thermoplastic | Thermoplastic |
| Non-Pyrogenic | Yes | Yes | Yes | Yes, LAL Test |
| Sterile Packaging | Tyvek pouch | Tyvek pouch | Tyvek pouch | Tyvek pouch |
| Sterilization Method | EO, SAL 10-6 | EO, SAL 10-6 | Gamma, 11137,VDMax25,SAL 10-6Dose: 25 - 40 kGy. | Gamma, 11137,VDMax25,SAL 10-6Dose: 25 - 40 kGy |
Performance Testing Summary
Performance testing confirms that the quality of the samples obtained with the M-CORE disposable core biopsy needle is substantially equivals of the samples obtailed with the M-CORE disposable con biopsy
needle is substantially equivalent to the predicate device(s). See Section 18
4325 Settingdown Circle, Suite 103
Cumming, GA 30028 phone: (678) 965 - 5334 fax: (678) 965 - 5343 www.insertmoldingsolutions.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the top right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Paul Hendrixson President Insert Molding Solutions, Inc. 4325 Settingdown Circle, Suite 103 CUMMING GA 30028
JUL 2 9 2011
Re: K111529
Trade/Device Name: M-CORE disposable core biopsy needle Regulation Number: 21 CFR$ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: June 27, 2011 Received: June 29, 2011
Dear Mr. Hendrixson:
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 of medical device-related
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Hubert Lehman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Insert Molding Solutions, Inc. The logo consists of a star with a medical symbol in the center, followed by the company name. The text is in a simple, sans-serif font and is aligned to the right of the star symbol. The logo is simple and professional, and it is likely used to represent the company's brand.
Indications for Use
K11529
510(k) Number (if known):
M-CORE disposable core biopsy needle
Indications For Use:
Device Name:
The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hlenin
(Division/Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111529
4325 Settingdown Circle, Suite 103
phone: (678) 965 - 5334 fax: (678) 965 - 5343 Cumming, GA 30028 www.insertmoldingsolutions.com
SECTION 4, PAGE 1 of 1
§ 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.