(199 days)
Not Found
No
The 510(k) summary describes a physical biopsy needle and syringe, with no mention of software, algorithms, or AI/ML terms.
No.
This device is identified as an aspiration cytology needle used for biopsy, which is a diagnostic procedure, not a therapeutic one.
Yes
The device is indicated for "biopsy of tumors," which is a diagnostic procedure used to determine the nature of a disease.
No
The device description clearly outlines physical components like needles, syringes, and plungers, indicating it is a hardware medical device.
Based on the provided information, the BioSuc Fine Aspiration Cytology Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "biopsy of tumors in the Thyroid, Breast or Lymph node." This describes a procedure to obtain a sample from the body.
- Device Description: The description details a needle and syringe, which are tools used for collecting a sample from the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens outside of the body (in vitro) to provide information about a patient's health. This device is used to collect the specimen.
Therefore, the BioSuc Fine Aspiration Cytology Needle is a device used for sample collection, which is a step that might precede an in vitro diagnostic test, but the needle itself is not an IVD.
N/A
Intended Use / Indications for Use
Biopsy of tumors in the Thyroid, Breast or Lymph Node, etc., and adjacent to the body surface.
The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
Needle size: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole 20G: 0 0.35 to 0 0.5 n=0 to 3
21G: φ 0.35 to φ 0.5 n=0 to 3
22G: ф 0.35 n=0 to 2
| Product Code No. | Needle size | Side Hole | Syringe |
|---|---|---|---|
| 22030500 | 20Gx50mm | $\phi$ 0.5 1 hole | 7 ml |
| 22030510 | 20Gx100mm | $\phi$ 0.5 1 hole | 7 ml |
| 22030520 | 21Gx50mm | $\phi$ 0.5 1 hole | 7 ml |
| 22030540 | 22Gx50mm | $\phi$ 0.35 1 hole | 7 ml |
E. DESORIE: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole
20G: φ 0.35 to φ 0.5 n=0 to 3
21G: φ 0.35 to φ 0.5 n=0 to 3
22G: φ 0.35 n=0 to 2
| Product Code No. | Needle size | Side Hole | Syringe |
|---|---|---|---|
| 22030500 | 20Gx50mm | φ 0.5 1 hole | 7 ml |
| 22030510 | 20Gx100mm | φ 0.5 1 hole | 7 ml |
| 22030520 | 21Gx50mm | φ 0.5 1 hole | 7 ml |
| 22030540 | 22Gx50mm | φ 0.35 1 hole | 7 ml |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thyroid, Breast, Lymph Node, and adjacent to the body surface.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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
K013108 1/:
HAKKO SHOJI CO., LTD 1. 7-9 Kamimeguro 1-Chome, Meguro-ku Tokyo 153 Japan 81-(3)-464-8500 Fax 81-(3)-464-8539
APR 0 4 2002
Contact person: M. Moruyama
- DEVICE NAME
Proprietary Name(s): BioSuc Common Name(s): Fine Aspiration Cytology Needle
Device Class: Class II 21CFR 876.1075 Aspiration biopsy needle (gastroenterology-urology biopsy instrument). Product Code: KNW
3. STATEMENT OF SUBSTANTIAL EQUIVALENCE:
Predicate Devices: Manan Medical Products, Inc. Westcott Aspiration Needle K943651 Allegiance Aspiration Needle K831392 Travenol Lab. Daum Aspiration Biopsy Needle K974575 Daum GMBH
The Biosuc Fine Aspiration Cytology Needle is substantially equivalent to the referenced predicated devices in that it is similar with respect to technological characteristics and intended use.
4. DESCRIPTION OF THE DEVICE(S)
Needle size: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole 20G: 0 0.35 to 0 0.5 n=0 to 3
21G: φ 0.35 to φ 0.5 n=0 to 3
22G: ф 0.35 n=0 to 2
| Product Code No. | Needle size | Side Hole | Syringe |
|---|---|---|---|
| 22030500 | 20Gx50mm | $\phi$ 0.5 1 hole | 7 ml |
| 22030510 | 20Gx100mm | $\phi$ 0.5 1 hole | 7 ml |
| 22030520 | 21Gx50mm | $\phi$ 0.5 1 hole | 7 ml |
| 22030540 | 22Gx50mm | $\phi$ 0.35 1 hole | 7 ml |
- STATEMENT OF INTENDED USE:
Biopsy of tumors in the Thyroid, Breast or Lymph Node, etc., and adjacent to the body surface.
1
K013108 2/2
- DESCRIPTION OF DEVICE(s): E. DESORIE: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole
20G: φ 0.35 to φ 0.5 n=0 to 3
21G: φ 0.35 to φ 0.5 n=0 to 3
22G: φ 0.35 n=0 to 2
| Product Code No. | Needle size | Side Hole | Syringe |
|---|---|---|---|
| 22030500 | 20Gx50mm | φ 0.5 1 hole | 7 ml |
| 22030510 | 20Gx100mm | φ 0.5 1 hole | 7 ml |
| 22030520 | 21Gx50mm | φ 0.5 1 hole | 7 ml |
| 22030540 | 22Gx50mm | φ 0.35 1 hole | 7 ml |
- PROPOSED LABELING: F. See attached (Page 46) Each Product Label will have the following information:
Complete product description
Manufactured by: Hakko Medical Co., Ltd.
Distributed by: Havel's Incorporated 3726 Lonsdale Street Cincinnati, Oh 45227 (513) 271-2117 Made in Japan
SINGLE USE ONLY STERILE
CAUTION: Do not use if package has been opened or damaged. Store in a cool, dry place. Federal law restricts this device to sale by or on the order of a physician.
Sterile unless opened or damaged
- STATEMENT OF INTENDED USE: G. Biopsy of tumors in the Thyroid, Breast or Lymph Node, etc., and adjacent to the body surface.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hakko Medical Company, Ltd. c/o Mr. Shiro Kitagawa Director, Marketing Division Hakko Shoji Co., Ltd. 7-9 Kamimeguro 1-Chome Meguro-Ku, Tokyo, Japan 153
APR 0 4 2002
Re: K013108
Trade/Device Name: BioSuc Fine Aspiration Cytology Needle Regulation Number: 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: December 14, 2001 Received: March 21, 2002
Dear Mr. Kitagawa:
We have reviewed your Section 510(k) premarket notification of intent to market the device in indication we have reviewed your Section 510(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regary many of the Medical Device American by the debecal Brush Brush commerce provided in accordance with the provisions of the Federal Food, Drug, devices that have bech recadssince in acce approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvise the general controls provisions of the Act. The You may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of the recess, 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 If your device is classince (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FRA this be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of I cases oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issualles or wouldwice complies with other requirements of the Act that IDA has made a acterimations administered by other Federal agencies. You must or any if ederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, me. and 801); good manufacturing practice requirements as set CFN Fatt 807), labeling (21 CFR Part 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Shiro Kitagawa
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w Jourse FDA finding of substantial equivalence of your device to a legally premative notification "The 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 and 11 you desire by of CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 0071 or questions on the promotion and advertising of Comphance at (301) 594-1697 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisolanany responsibilities under the Act may be obtained from the Outer general information of you 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,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KO(3108
Device Name Big Suc Firme Aspination Cutology Needle
Indications For Use:
The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrente of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Poplional Formar 1-2-96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013108