(176 days)
Not Found
No
The 510(k) summary describes a mechanical aspiration needle and its components. There is no mention of AI, ML, image processing, or any software-driven analysis of the ultrasonic visualization. The device appears to be a traditional medical instrument.
No
The device is described as an aspiration needle intended to obtain tissue samples for diagnostic purposes, not to treat a disease or condition.
Yes
Explanation: The device is used to obtain tissue samples ("percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues") for diagnosis, which is a key function of diagnostic devices.
No
The device description clearly outlines physical components such as needles, syringes, and filter paper, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Sonopsy Aspiration Needle Function: The Sonopsy aspiration needle is used to obtain tissue samples from within the body using ultrasonic visualization. It's a tool for collecting the specimen, not for analyzing it.
The device's purpose is to facilitate the collection of tissue, which would then likely be sent to a laboratory for in vitro analysis (which would be performed using IVD devices). The Sonopsy needle itself is a surgical/procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.
Product codes (comma separated list FDA assigned to the subject device)
FCG, 78 FCG
Device Description
Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic visualization
Anatomical Site
abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues
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)
Not Found
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
510(K) SUMMARY
-
HAKKO SHOJI CO., LTD 1. 7-9 Kamimeguro 1-Chome, Meguro-ku Tokyo 153 Japan 81-(3)-464-8500 Fax 81-(3)-464-8539
Contact person: M. Moruyama -
- DEVICE NAME SONOPSY Proprietary Name(s): Aspiration biopsy needle Common Name(s):
Classification: Aspiration biopsy needle (gastroenterology-urology biopsy instrument). 21CFR 876.1075 Class II Product Code: FCG
- DEVICE NAME SONOPSY Proprietary Name(s): Aspiration biopsy needle Common Name(s):
STATEMENT OF SUBSTANTIAL EQUIVALENCE: 3.
Predicate Device:
| INRAD/MANAM | Accucore Biopsy Needle | K981166 |
|---|---|---|
| E-Z-EM, INC. | Lufkin Aspiration Needle | K882601 |
| DAUM Corp. | DAUM AspirationNeedle | K974575 |
The Sonopsy Aspiration Biopsy Needle is substantially equivalent to the referenced predicated devices in that it is similar with respect to technological characteristics and intended use.
DESCRIPTION OF THE DEVICE(S): 4.
Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces
| Product
Code No. | Needle size | Needle
tip | Inner
needle
tip | Syringe | Guide
needle size | Guide needle
tip | Filter
paper |
|---------------------|-------------|-----------------|------------------------|---------|----------------------|---------------------|-------------------|
| 22032170 | 21Gx170mm | Biopsy
point | Pencil
point | 7 ml | 18Gx70mm | Lancet point | 20x35
3 pieces |
| 22032180 | 21Gx180mm | Biopsy
point | Pencil
point | 7 ml | 18Gx70mm | Lancet point | 20x35
3 pieces |
న. STATEMENT OF INDENDED USE
The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2002
Mr. Shiro Kitagawa Director, Marketing Division Hakko Shoji Co., Ltd. 7-9 Kamimeguro 1-Chome, Meguro-ku, Tokyo 153 JAPAN
Re: K013109 Trade/Device Name: HAKKO Sonopsy Biopsy Needle Set Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: December 21, 2001 Received: December 26, 2001
Dear Mr. Kitagawa
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.
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); 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.
2
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or Compilance w ( rotification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KOT 370
510(k)NUMBER (IF KNOWN) K013109
DEVICE NAME: Aspiration Biopsy Needle
INDICATION FOR USE:
The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.
David C. Byrom
(Division Sign-Om
4
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KOB109
(please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFE 801.109) OR
Over-The-Counter-Use (Options Format 1-2-9