(185 days)
Not Found
No
The device description focuses on mechanical components and vacuum-assisted tissue acquisition. There is no mention of AI/ML in the device description, intended use, or performance studies. The input imaging modalities are standard medical imaging techniques, and there is no description of any AI/ML training or test sets.
No.
The device is used to obtain biopsy samples for diagnosis, not to apply therapy or treat a condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "When used for breast biopsy, the product is for diagnosis only." This indicates its role in determining the nature of an abnormality, which is a diagnostic purpose.
No
The device description clearly details physical components made of stainless steel and a mechanical mechanism for tissue acquisition, indicating it is a hardware device.
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").
- This Device's Function: This device is a biopsy device. Its primary function is to obtain a tissue sample from the patient's body ("in vivo"). While the analysis of the tissue sample obtained by this device will be an in vitro diagnostic process (performed in a lab), the device itself is a tool for sample collection, not for performing the diagnostic test itself.
- Intended Use: The intended use clearly states "To obtain percutaneous core biopsy samples". This describes a procedure to collect tissue, not to perform a diagnostic test on a sample.
- Device Description: The description details the mechanical process of acquiring a tissue sample from within the body.
Therefore, based on the provided information, this device is a surgical instrument or biopsy device used for sample collection, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only.
The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Evacore Fully Disposable Vacuum Assist Biopsy Device is a gamma sterilized, single-use percutaneous biopsy device. The working end of the device consist of a stainless steel outer needle with a lateral aperture for sample acquisition (sample aperture), a stainless steel inner cutting cannula with a sharp edge, and a solid stainless steel stylet located inside the cutting cannula. The handle of the device contains (2) release buttons, a reset handle for the vacuum generator (thumb), a reset handle for the cutting cannula (two fingers), and a needle hub to adjust the needle aperture orientation based on the location of the lesion. When the release buttons are depressed (consecutively or concurrently) a vacuum is generated at the needle sample aperture drawing tissue into the needle, then the cutting cannula is activated automatically, traversing across the sample aperture dissevering the tissue sample. The solid stainless steel stylet prevents the tissue sample from migrating towards the handle once it has been separated from the patient. The device is then removed from the patient and reset via the reset handles allowing the tissue sample to be removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's Office or O.R.
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 Evacore Fully Disposable Vacuum Assist Biopsy Device was performance tested using empirical testing.
Results:
- 7 gauge 115mm & 145mm needle length tissue, average volume of a sample > .105cm3 (PASS)
- 11 gauge 115mm & 145mm needle length tissue, average volume of a samples >.033cm3 (PASS)
- 14 gauge 115mm & 145mm needle length tissue, average mass of 8 samples > .018cm3 (PASS)
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.
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.
Not Found
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 is the logo for the Department of Health and Human Services (HHS). The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the first profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pin-Point Care Corporation Mr. Jeff M. Hathaway President N1723 Center Street Lebanon, Wisconsin 53047
July 20, 2015
Re: K150088
Trade/Device Name: Evacore Fully Disposable Vacuum Assist Biopsy Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: June 26, 2015 Received: June 26, 2015
Dear Mr. Hathaway:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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,
Joshua
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
Pin-Point Care
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150088
Device Name
Evacore Fully Disposable Vacuum Assist Biopsy Device
Indications for Use (Describe)
To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only.
The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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"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
Pin-Point Care
Date Prepared:
30 December, 2014
510(k) Summary
(As required per 21 CFR: §807.92)
Evacore Fully Disposable Vacuum Assist Biopsy Device
I. Applicant Information:
Pin-Point Care Corporation N1723 Center Street Lebanon, WI 53047
II. Contact Person:
| Jeff M. Hathaway |
|---|
| Phone Number........................(262)623-1149 |
| Fax Number........................(262)806-7499 |
| Email........................................jeff.hathaway@pin-pointcare.com |
III. Device Information:
| Classification | Class II |
|---|---|
| Trade Name | Evacore Fully Disposable Vacuum |
| Assist Biopsy Device | |
| Common Name | Biopsy Instrument |
| Classification Name | Gastroenterology-Urology Biopsy |
| Instrument (21 CFR 876.1075) | |
| Panel | 78 Gastroenterology/Urology |
| Product Code | KNW |
Predicate Device Information: IV.
| Manufacturer | Hologic - Suros Surgical Systems |
|---|---|
| Device | Celero Vacuum Assisted Spring Loaded Core Biopsy Device |
| 510(k) Number | K034021 |
V. Device Description:
The Evacore Fully Disposable Vacuum Assist Biopsy Device is a gamma sterilized, single-use percutaneous biopsy device. The working end of the device consist of a stainless steel outer needle with a lateral aperture for sample acquisition (sample aperture), a stainless steel inner cutting cannula with a sharp edge, and a solid stainless steel stylet located inside the cutting cannula. The handle of the device contains (2) release buttons, a reset handle for the vacuum generator (thumb), a reset handle for the cutting cannula (two fingers), and a needle hub to adjust the needle
4
aperture orientation based on the location of the lesion. When the release buttons are depressed (consecutively or concurrently) a vacuum is generated at the needle sample aperture drawing tissue into the needle, then the cutting cannula is activated automatically, traversing across the sample aperture dissevering the tissue sample. The solid stainless steel stylet prevents the tissue sample from migrating towards the handle once it has been separated from the patient. The device is then removed from the patient and reset via the reset handles allowing the tissue sample to be removed.
VI. Indications for Use:
The Evacore Fully Disposable Vacuum Assist Biopsy Device is a Biopsy Instrument as described under the provisions of 21 CFR §876.1075 and is medically prescribed to obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only.
The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures.
VII. Device Comparison:
Note: Unless otherwise stated, the Device Comparison for the Evacore Fully Disposable Vacuum Assist Biopsy Device is for all noted needle lengths and gauges.
| Comparison | Predicate Device - (K034021)
Vacuum Assisted Spring
Loaded Core Biopsy Device | Evacore Fully Disposable
Vacuum Assist Biopsy Device |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use | To obtain percutaneous core
biopsy samples from soft tissue
and tumors of such organs as
the liver, spleen, kidney,
prostate, lung, breast, and
lymph nodes. When used for
breast biopsy, the product is
for diagnosis only. | Same |
| Target Population | Patients with suspicious soft
tissue lesion(s) | Same |
| Product Code | KNW | Same |
| Outer Needle Diameter(s) | 12 Guage | 7, 11, and 14 Guage |
| Needle Length | ≈123mm | 115mm and 145mm |
| Number of samples | Unknown | 16 samples |
| Method of Device
Insertion | Working end of the device
introduced without or with
coaxial introducer | Same |
| Method of Tissue Collection | Insert the needle in the correct position, activate the device and wait for the device to finish cycling (automatic), remove the device from the patient, reset the device and manually extract the tissue sample. | Same |
| Optimal Sample Notch Length | 22mm | 19mm |
| Core Type | Partial Diameter | Full Diameter |
| Weight | 135g | 95g, 84g, and 79g
(145mm needle length) |
| Selectable Sample Length | No | Yes (19mm or 11mm length) |
| Echogenic Needle Description: Used for enhancing ultrsound imaging. | Yes | Yes |
| Disposable Device | Fully disposable single patient use | Same |
| Device Sterility | Gamma Sterilization | Same |
| Sterile Barrier | Thermoformed tray with heat sealed Tyvek™ cover | Same |
| Shelf Life | 3 years | Same |
| Electrical Safety | The device operates on mechanical principles only. Therefore, the device has no electrical components | Same |
| Method of Tissue
Dissection | Cutting cannula advances across tissue aperture | Same |
| Mechanics of action | Automatic | Same |
| Needle Advancement/
Penetration Depth | 25mm | N/A |
| Mode of Action | Single puncture and sample, or
single puncture and multiple
samples with introducer | Same |
| Non-Contact Materials | Colored polymer housings with
metal springs as the energy
source | Same |
| Patient Contact Materials | 300 Series Stainless Steel | Same |
| Vacuum Energy Source | Spring operated vacuum
generator | Same |
| Cutting Cannula Energy
Source | Spring operated cutting
cannula | Same |
| Dual interlocks (manual)
for vacuum generator
release | No | Yes |
| Dual interlocks (automatic)
for cutting cannula release | No | Yes |
| Rotating Cutting Cannula | No | Yes |
| Manual reset of the device | Yes | Yes |
| Hand-Held Procedure | Yes | Yes |
| Location Used | Physician's Office or O.R. | Same |
| Prescription vs. O.T.C. | Prescription | Same |
| Performance | Equivalency to white paper
performance data | Bench test equivalency |
| Method of placement | CT/Ultrasound/Fluoroscopy/
Manual | Same |
Predicate Device Comparison Table
5
Traditional 510(k) Evacore Fully Disposable Vaccum Assist Biopsy Device
6
VIII. Non-Clinical Performance Data:
The Evacore Fully Disposable Vacuum Assist Biopsy Device was performance tested using empirical testing.
7
| Risk | Test Method | Acceptance Criteria | Results |
|---|---|---|---|
| 7 gauge 115mm & 145mm | |||
| needle length tissue | |||
| sample size is inadequate | Simulated and | ||
| supported with | |||
| bench testing | Average volume of a sample > .105cm3 | PASS | |
| 11 gauge 115mm & 145mm | |||
| needle length tissue | |||
| sample size is inadequate | Simulated and | ||
| supported with | |||
| bench testing | Average volume of a samples >.033cm3 | PASS | |
| 14 gauge 115mm & 145mm | |||
| needle length tissue | |||
| sample size is inadequate | Simulated and | ||
| supported with | |||
| bench testing | Average mass of 8 samples > .018cm3 | PASS |
Summary of Non-Clinical Performance Data
IX. Substantial Equivalency:
The flow chart shown below is a duplicate of the one that can be found in "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" in "Appendix A. 510(k) Decision-Making Flowchart". The pathway illustrates how the Evacore Fully Disposable Vacuum Assist Biopsy Device is substantially equivalent to the legally marketed predicate device.
The Predicate Device Comparison Table demonstrates that the Evacore Fully Disposable Vacuum Assist Biopsy Device has the same technological characteristics as the predicate device in terms of but not limited to, intended use, energy source, operating principals, optimal sample notch length, target population, device sterility, and method of tissue collection.
Conclusion:
Based on the Non-Clinical Performance Data provided in this summary, the Evacore Fully Disposable Vacuum Assist Biopsy Device has been shown to be substantially equivalent to the predicate device.
Note: See following page for flow chart.