(58 days)
Not Found
No
The 510(k) summary describes a mechanical device for bladder drainage and makes no mention of AI or ML technology.
Yes
The device is intended for bladder drainage, which is a therapeutic intervention to manage a patient's condition.
No
The device is described as a catheter and collection bag assembly intended for draining urine from the bladder, not for diagnosing a condition or disease.
No
The device description clearly states it is a catheter and collection bag assembly, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bladder drainage." This is a physical intervention to remove a bodily fluid, not a test performed in vitro (outside the body) on a sample of bodily fluid to diagnose a condition.
- Device Description: The description details a catheter and collection bag assembly used for inserting a catheter into the bladder to drain urine. This is a medical device used for a therapeutic or procedural purpose, not for diagnostic testing.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, analysis of samples, or the use of reagents or assays typically associated with IVDs.
Therefore, the Self-Cath® CS Closed System is a medical device used for bladder drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.
Product codes (comma separated list FDA assigned to the subject device)
FCM, KOD
Device Description
The Coloplast Self-Cath® CS Closed System catheter (also referred to as "SCCS") is an extension of the existing Coloplast Self-Cath product line. The device is a modification of the Coloplast (Mentor) Self-Cath Closed System catheter, which was cleared under 510(k) K003873. It is available singly and as part of a kit.
The SCCS is intended to be used to drain urine from the bladder. The SCCS is a catheter and collection bag assembly for inserting a catheter from a closed, sterile bag through an insertion tip into the bladder. It consists of a sterile, pre-lubricated catheter with a pre-lubricated introducer tip on the proximal end, which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter and introducer tip are pre-lubricated with a water-soluble hydrophilic water-based lubricant. The catheter provides a conduit for draining the bladder into the pre-attached urine collection bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra
Indicated Patient Age Range
male or female patients (no specific age range provided)
Intended User / Care Setting
patient, once appropriate training has taken place, or by a trained health care professional.
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
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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
. Attachment I – 510(k) Summary
JUN - 1 2007
510(k) Summary
Self-Cath® CS Closed Urinary Catheterization System
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
The assigned 510(k) number is: K070939
Contact Person:
Rebeka A. Stoltman
Manager, Regulatory Affairs
Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411
Telephone: (800) 788-0293, ext. 4997
Facsimile: (612) 287-4138
Email: usrst@coloplast.com
Date Prepared: April 3, 2007
Device Name and Classification
| Trade Name: | Self-Cath® CS Closed Urinary Catheterization System |
|---|---|
| Common Name: | Intermittent Urethral Urinary Catheter |
| Classification Name: | Urological Catheter and Accessories |
| Product Code: | FCM and KOD |
Legal Manufacturer
Coloplast A/S Holtedam 1 3050 Humlebaek, Denmark
1
Manufacturing Site (Catheter)
Coloplast Manufacturing US, LLC 1601 West River Road Minneapolis, MN 55411 USA
Manufacturing Site (Assembly & Packaging)
Shanghai Amsino Medical Devices Co., Ltd. 668 Hua Jiang Road Shanghai, P.R. China 201803
Device Description
The Coloplast Self-Cath® CS Closed System catheter (also referred to as "SCCS") is an extension of the existing Coloplast Self-Cath product line. The device is a modification of the Coloplast (Mentor) Self-Cath Closed System catheter, which was cleared under 510(k) K003873. It is available singly and as part of a kit.
The SCCS is intended to be used to drain urine from the bladder. The SCCS is a catheter and collection bag assembly for inserting a catheter from a closed, sterile bag through an insertion tip into the bladder. It consists of a sterile, pre-lubricated catheter with a pre-lubricated introducer tip on the proximal end, which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter and introducer tip are pre-lubricated with a water-soluble hydrophilic water-based lubricant. The catheter provides a conduit for draining the bladder into the pre-attached urine collection bag.
Substantial Equivalence Claim
Coloplast believes the proposed Self-Cath® CS Closed System is substantially equivalent in form and function to Coloplast's Self-Cath Closed System, which was cleared under 510(k) K003873.
Indications for Use
The Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebeka Stoltman Manager, Regulatory Affairs Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 55411
JUN - 1 2007
Re: K070939
Trade/Device Name: Self-Cath® CS Closed Urinary Catheterization System Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: FCM Dated: April 30, 2007 Received: May 4, 2007
Dear Ms. Stoltman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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.
3
Page 2 - Ms. Rebeka Stoltman
In addition, we have determined that your device kit contains povidone iodine swabsticks and benzalkonium chloride towelettes, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your Section 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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,
Nancy C Brogdon
ogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment C - Indications for Use Statement
Indications for Use Statement
070929
510(k) Number (if known):
Device Name: Self-Cath® CS Closed Urinary Catheterization System
Indications for Use:
Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.
Prescription Use X (21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdo minal. and Radiological Devices 510(k) Number.
Special 510(k): Device Modification
- Confidential -
Self-Cath® CS Closed Urinary Catheterization System