(84 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic functionality of a needle for delivering injections, with no mention of AI or ML technologies.
No.
The Bonee Needle is an accessory device used to deliver injectable materials, not to directly treat a condition. Its function is limited to drug delivery, which makes it a delivery device rather than a therapeutic one itself.
No
Explanation: The device is described as a needle used to deliver injectable materials into the urinary bladder wall, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components such as thermoplastic tubing, a stainless steel needle, connectors, and a protective cap, 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during a procedure. It is a tool used directly on the patient's body for a therapeutic or diagnostic procedure, not for testing samples outside the body.
The description clearly indicates it's a surgical/procedural device used for direct intervention within the body.
N/A
Intended Use / Indications for Use
The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The needle for bladder injections is designed for a working endoscope channel inner diameter of 5 French or larger.
This product is 35 cm (ref: NBI035) or 70 cm (ref: NBI070) length and is made of thermoplastic tubing polyamide (PA) marked by ink, a stainless steel cystoscopic needle, a polyamide Luer Lock connector and a Tuohy Borst adapter to allow connection with the cystoscope.
The assembly of the different components is being insured by gluing (UV process).
A blue protective cap in Neoplex® is also supplied to prevent cystoscope channel degradation during needle insertion.
Shelf life of the full range of the needle for bladder injections is 2 years. The needle for bladder injections is provided sterile and is intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder wall
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)
Substantial equivalence is supported by bench testing comparing Bonee Injection needle to the predicate devices and biocompatibility testing performed on the Bonne Needle.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Page 1 of 2
5
510(k) SUMMARY
(as required by section 807.92(c)
APR 2 3 2009
510(K) Owner's Name:
Address:
Holtedam 1 3050 Humlebaek, Denmark
Coloplast A/S
Office:
Phone/Fax/Email:
(612) 226-3040 Mobile: Fax: (612) 287-4138 Email: usskg@coloplast.com
(612) 287-4174
Name of Contact Person:
Trade Or Proprietary Name:
Common Or Usual Name:
Classification Name:
Suresh Ghai Regulatory Affairs Manager
Date Prepared:
January 29th, 2009
Bonee Needle for Bladder Injections
Endoscopic Injection Needle
Endoscope and accessories (21CFR section 876.1500) (Product Code: FBK) Device Class: 2
Legally Marketed Device To Which Your Firm Is Claiming Equivalence:
The Bonee Needle for Bladder Injections is substantially equivalent in performance, indication, design and materials to Cook Injection Needles from Cook Urological, Inc., cleared under Premarket notification # K022484.
Device Description:
The needle for bladder injections is designed for a working endoscope channel inner diameter of 5 French or larger.
This product is 35 cm (ref: NBI035) or 70 cm (ref: NBI070) length and is made of thermoplastic tubing polyamide (PA) marked by ink, a stainless steel cystoscopic needle, a polyamide Luer Lock connector and a Tuohy Borst adapter to allow connection with the cystoscope.
1
K090217
page 2 of 2
The assembly of the different components is being insured by gluing (UV process).
A blue protective cap in Neoplex® is also supplied to prevent cystoscope channel degradation during needle insertion.
Shelf life of the full range of the needle for bladder injections is 2 years. The needle for bladder injections is provided sterile and is intended for single use.
Image /page/1/Figure/4 description: The image shows a long, thin object that is curved in an arc. The object appears to be made of a dark material. The object is positioned horizontally across the frame, with the left end of the object being higher than the right end. The right end of the object is partially obscured by some dark shapes.
Figure 1: Bonee Needle for Bladder Injections
Product variants available:
| Reference | Length (cm) | Use | Body diameter (mm) | Needle tip |
|---|---|---|---|---|
| NBI035 | 35 | With rigid cystoscope | 1.7 mm (= 5 CH/FR) | Chiba tip (22G) |
| NBI070 | 70 | With flexible cystoscope | 4 mm in length |
Table 2. Sizes and codes of the needle for bladder injections
Intended Use Of The Device:
: _ǐ
The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
Technological Characteristics Compared To Predicate Device:
The Bonee Needle for Bladder Injections is substantially equivalent in performance, indication, design and materials to Cook Injection Needles from Cook Urological, Inc., cleared under Premarket notification # K022484.
Summary and Conclusions from the Nonclinical Tests Submitted:
Substantial equivalence is supported by bench testing comparing Bonee Injection needle to the predicate devices and biocompatibility testing performed on the Bonne Needle.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2009
Mr. Suresh Ghai Regulatory Affairs Manager Coloplast A/S 1601 West River Road N MINNEAPOLIS MN 55411
Re: K090217
Trade/Device Name: Bonee Needle for Bladder Injections Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: April 2, 2009 Received: April 3, 2009
Dear Mr. Ghai: .
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 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 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)
(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
4 INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K090217
Device Name: Bonee Needle for Bladder Injections
Indications for Use:
The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
luzi Whting
(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number