(86 days)
No
The provided text describes a mechanical biopsy system and does not mention any AI or ML components or functionalities.
No.
This device is used for obtaining biopsy samples, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is used to obtain tissue samples for "diagnostic sampling of breast abnormalities" and "histologic examination," which are indicative of its use in the diagnostic process.
No
The device description clearly indicates it is a physical system used to remove tissue specimens by cutting, which is a hardware function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is used to obtain the specimen (tissue sample) from the body.
- The intended use and device description clearly state that the device is for obtaining core biopsy samples. This is a procedure performed on the patient to collect tissue.
- There is no mention of the device analyzing or testing the tissue sample itself. The tissue sample obtained by this device would then be sent to a laboratory for analysis, which would likely involve IVD procedures.
In summary, this device is a biopsy device, which is a surgical instrument used to collect tissue samples. It is a crucial step in the diagnostic process, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
Intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.
The Achieve Programmable Automatic Biopsy System is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
Product codes
KNW
Device Description
The Achieve® Programmable Automatic Biopsy Systems are used to remove, by cutting, a specimen of tissue for microscopic evaluation. The organs in which the device may be used include but are not limited to breast, kidney, liver, prostate, spleen and lymph nodes plus various soft tissue masses. The device provides precise control and quality sampling capability when working with calcified or fibrous lesions. The lightweight system offers spring-loaded action for fast, accurate penetration of dense tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses.
breast tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence:
- Biocompatibility: AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing
- Residuals: AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
- Performance:
- BS EN ISO 9626:1995: Stainless Steel Needle Tubing for the Manufacture of Medical Devices.
- ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods
- ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization
- ISO 11138:1 2006 Sterilization of Healthcare Products, Biological Indicators
- AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization
- ANSI/AAMI/ISO 11607:2006 Packaging for Terminally Sterilized Medical Devices
- ASTM F899-95 Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical Instruments
- ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems
- BS/EN/ISO 9626:1995 Stainless Steel Needle Tubing for the Manufacture of Medical Devices
- Biopsy Sample Testing - Comparison of samples obtained by predicate and proposed devices to prove equivalency.
- Weld Strength Testing - Verification of the proposed device stylet weld strength to ensure safety and effectiveness.
- Firing Speed Testing - Comparison of the firing speeds of the predicate and proposed devices to prove equivalency.
- Ultrasound Visibility Testing - Verification of the proposed device ultrasound visibility to ensure safety and effectiveness.
The results of the non-clinical tests show the CareFusion Achieve Programmable Automatic Biopsy Systems meet or exceed all performance requirements, and are substantially equivalent to the predicate devices.
Summary of Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information:
N/A – No clinical tests were conducted for this submission.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
CareFusion Ms. Joy Greidanus Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, IL 60061
Re: K141552
Trade/Device Name: Achieve Programmable Automatic Biopsy Systems Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: June 10, 2014 Received: June 11, 2014
Dear Ms. Greidanus:
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
Indications for Use
510(k) Number (if known) K141552
Device Name
Achieve Programmable Automatic Biopsy System
Indications for Use (Describe)
Intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone.
The Achieve Programmable Automatic Biopsy System is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essue margins be examined for completeness of removal using standard surgical procedures.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) SUMMARY K141552
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion |
| Address | 75 North Fairway Drive, Vernon Hills, IL 60061 USA |
| Phone number | (847) 362-8103 |
| Fax number | (312) 949-0583 |
| Establishment Registration | |
| Number | 1423507 |
| Name of contact person | Joy Greidanus |
| Date prepared | August 26, 2014 |
| DESCRIPTION OF DEVICE | |
| Trade or proprietary name | Achieve Programmable Automatic Biopsy Systems |
| Common or usual name | Soft Tissue Biopsy Needle |
| Classification name | Instrument, Biopsy |
| Classification panel | Gastroenterology/Urology |
| Regulation | Class II per 21CFR §876.1075 |
| Product Code(s) | KNW |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed | K960064 CareFusion Achieve (Formerly Bauer Medical) |
| and K133948 Bard Monopty | |
| Reason for 510(k) | |
| submission | Updates to labeling and device modifications. |
| Device description | The Achieve® Programmable Automatic Biopsy Systems are used to remove, |
| by cutting, a specimen of tissue for microscopic evaluation. The organs in | |
| which the device may be used include but are not limited to breast, kidney, | |
| liver, prostate, spleen and lymph nodes plus various soft tissue masses. The | |
| device provides precise control and quality sampling capability when working | |
| with calcified or fibrous lesions. The lightweight system offers spring-loaded | |
| action for fast, accurate penetration of dense tissue. | |
| Intended use of the device | The Achieve Programmable Automatic Biopsy System is intended for use in |
| obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, | |
| spleen, lymph nodes, and various soft tissue masses. Not intended for use in | |
| bone. |
The Achieve Programmable Automatic Biopsy System is also indicated to
provide breast tissue samples for diagnostic sampling of breast abnormalities.
It is designed to provide breast tissue for histologic examination with partial or
complete removal of the imaged abnormality. |
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
4
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | New Device | Predicates |
|---|---|---|
| Mode of Action | Single Puncture and Multiple Samples | Same as predicates: K960064 CareFusion |
| Achieve (Formerly Bauer Medical) and | ||
| K133948 Bard Monopty | ||
| Firing modes | Automatic and Delay | Same as predicate: K960064 CareFusion |
| Achieve | ||
| Anatomical Sites | Breast, kidney, liver, prostate, spleen, | |
| lymph nodes and various soft tissue | ||
| masses | Same as predicate: K960064 CareFusion | |
| Achieve (Formerly Bauer Medical) and | ||
| K133948 Bard Monopty | ||
| CONCLUSION OF DEVICE COMPARISON | ||
| The technological characteristics of the proposed devices are substantially equivalent to the predicate. | ||
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | ||
| EQUIVALENCE | ||
| Characteristic | Standard/Test/FDA Guidance | |
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation | |
| and Testing | ||
| Residuals | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene | |
| Oxide Sterilization Residuals | ||
| Performance | BS EN ISO 9626:1995: Stainless Steel Needle Tubing for the Manufacture of Medical | |
| Devices. | ||
| Performance | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods | |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide | |
| Sterilization | ||
| Performance | ISO 11138:1 2006 Sterilization of Healthcare Products, Biological Indicators | |
| Performance | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide | |
| Sterilization | ||
| Performance | ANSI/AAMI/ISO 11607:2006 Packaging for Terminally Sterilized Medical Devices | |
| Performance | ASTM F899-95 Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical | |
| Instruments | ||
| Performance | ASTM F1980-07 Accelerated Aging of Sterile Barrier Systems | |
| Performance | BS/EN/ISO 9626:1995 Stainless Steel Needle Tubing for the Manufacture of Medical | |
| Devices | ||
| Performance | Biopsy Sample Testing - Comparison of samples obtained by predicate and proposed | |
| devices to prove equivalency. | ||
| Performance | Weld Strength Testing - Verification of the proposed device stylet weld strength to ensure | |
| safety and effectiveness. | ||
| Performance | Firing Speed Testing - Comparison of the firing speeds of the predicate and proposed | |
| devices to prove equivalency. | ||
| Performance | Ultrasound Visibility Testing - Verification of the proposed device ultrasound visibility to | |
| ensure safety and effectiveness. |
5
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A – No clinical tests were conducted for this submission
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests show the CareFusion Achieve Programmable Automatic Biopsy Systems meet or exceed all performance requirements, and are substantially equivalent to the predicate devices.