(83 days)
No
The device description and performance studies focus on the mechanical and material properties of a simple urinary catheter, with no mention of AI or ML.
Yes
The device is used to drain the bladder in patients unable to promote natural urine flow or with significant residual urine, which is a therapeutic intervention.
No
Explanation:
The device description and intended use indicate that the PerfIC Cath™ is a urinary catheter used for bladder drainage when natural urine flow is impaired. It is a tool for therapy and management of a condition (urinary retention), not for identifying or diagnosing a medical condition or disease.
No
The device description clearly states it is a physical urinary catheter made of PVC tubing with eyelet holes and a collection bag, indicating it is a hardware device.
Based on the provided information, the PerfIC Cath™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for bladder drainage in adult male patients. This is a direct intervention on the body to manage a physiological function (urine flow), not to diagnose a condition by examining samples outside the body.
- Device Description: The device is a physical catheter designed to be inserted into the urethra and bladder to facilitate urine drainage. It does not involve the analysis of biological samples like blood, urine, or tissue in a laboratory setting.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The PerfIC Cath™ is a therapeutic device used for managing a physical condition.
N/A
Intended Use / Indications for Use
The PerfIC Cath™ is intended for use in adult male patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The PerfIC Cath™ is a single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in length, with two (2) oval eyelet holes for intra-bladder urine drainage at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. The product will be available in a straight and Coude tip configuration (also termed a Tiemann tip). Additionally, the PerfiC Cath™ will be offered with either aqueous gel lubricant or hydrophilic coating. The distal end of the catheter is connected to a PVC urine collection bag. The product is available in a 14French only.
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
adult male patients, adult male and adult female patients
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)
The modified PerflC Cath™ catheters have been tested as required for design verification and validation. Design verification and validation testing of the new versions of the intermittent catheter included the following tests.
Mechanical Integrity
Advancement Force
Biocompatibility
The product performance test results support substantial equivalence between the predicate PerfIC Cath™ and the modified PerfIC Cath™.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2016
Adapta Medical, Inc. % Neil Burris Regulatory Consultant Neil Burris & Associates 4250 Grove Street Denver. CO 80211
Re: K161445 Trade/Device Name: PerfIC Cath Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: July 20, 2016 Received: July 21, 2016
Dear Neil Burris:
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.
1
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.
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" (21 CFR 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.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be printed on a white background. The name is written in a clear and legible typeface.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) Not Known K161445
Device Name PerfIC Cath
Indications for Use (Describe)
The PerfIC Cath™ is intended for use in adult male patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Section 6: 510(k) Summary
The following information is provided as required by 21 CFR §807.92 for the PerfIC Cath™ Urinary Catheter System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
Sponsor:
Adapta Medical 142 Talamine Court Colorado Springs, CO 80907
Contact:
Name: Neil Burris Title: Regulatory Consultant – Adapta Medical Phone: 720 323 1662 Fax: 720 746 6390 E-mail: neil@sssnpartners.com
Submission Date: May 24, 2016
Proprietary Name: PerfIC Cath™ Common Name: Urologic Catheter and Accessories Regulation: 21 CFR §876.5130 Regulatory Class: Class II Product Code: EZD Predicate Device(s): Primary - Adapta Medical: PerfIC Cath™ (K103043) Secondary "Reference" Predicate - Hangzhou Bever Medical Device Co., Ltd.: Bever Medical Intermittent Catheters (K111405)
Device Description:
The PerfIC Cath™ is a single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in length, with two (2) oval eyelet holes for intra-bladder urine drainage at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. The product will be available in a straight and Coude tip configuration (also termed a Tiemann tip). Additionally, the PerfiC Cath™ will be offered with either aqueous gel lubricant or hydrophilic coating. The distal end of the catheter is connected to a PVC urine collection bag. The product is available in a 14French only.
Intended Use:
The PerflC Cath™ is intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
4
Summary of the Technological Characteristics Comparison to Predicate Device:
The PerfIC Cath™ has the same intended use and fundamental scientific technology as the predicate device. They are urinary catheters for intermittent use, with flexible insertion tips and lubricated catheter tubes for patient comfort and easy insertion, and with outer sheaths over the catheter per se so that a user can more easily maintain clean technique.
The only differences between the predicate device and the proposed device are the additional offering of curved Coude tip (Tiemann tip) versions, and hydrophilically coated versions as an alternative to aqueous gel lubricant. Versions with hydrophilic coating include a sterile water sachet for activation of the lubricant coating.
Performance Data Summary:
The modified PerflC Cath™ catheters have been tested as required for design verification and validation. Design verification and validation testing of the new versions of the intermittent catheter included the following tests.
Mechanical Integrity Advancement Force Biocompatibility
The product performance test results support substantial equivalence between the predicate PerfIC Cath™ and the modified PerfIC Cath™.
Substantial Equivalence:
The proposed PerfIC Cath™ device line has the same indication for use and fundamental scientific technological characteristics as the predicate device. Based on this, the design and the summary of design control activities provided in this submission, the proposed device has been shown to be substantially equivalent to the PerfIC Cath™ cleared to market under 510(k) K103043. Refer to the table below for a listing of the points compared for substantial equivalence. The modified PerfIC Cath™ devices are all substantially equivalent to the predicate PerfiC Cath™, and the curved Coude tip is substantially equivalent to the Tiemann Tip of the reference predicate, the Bever Intermittent Catheter (K111405).
Continued next page
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Comparison Table Showing Substantial Equivalence between PerfIC Cath™ and predicate PerfIC Cath™
| Device
Attribute | PerfIC Cath™ [Straight and
Coude Tip Models with either
Gel or Hydrophilic Coating | PerfIC Cath™ original Kit
K103043 | Equivalent |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PerfIC Cath™ is intended for
use in adult male and adult
female patients requiring bladder
drainage as determined by their
physician. This device is
indicated for those individuals
who are unable to promote
natural urine flow or for those
individuals who have a significant
volume of residual urine
following a natural bladder-
voiding episode. | The PerfIC Cath™ is intended
for use in adult male and adult
female patients requiring
bladder drainage as determined
by their physician. This device is
indicated for those individuals
who are unable to promote
natural urine flow or for those
individuals who have a
significant volume of residual
urine following a natural
bladder-voiding episode. | Identical |
| Packaging | Pouched kit containing catheter
assembly, benzalkonium
disinfectant wipe, and plastic
hook; thumb holes to facilitate
opening by limited dexterity
patients. | Pouched kit containing catheter
assembly, gauze sponge,
procedure gloves, and
benzalkonium disinfectant wipe,
and plastic hook; thumb holes to
facilitate opening by limited
dexterity patients. | Substantially
Equivalent |
| Labeling | Adhesive-backed label with
preprinted information applied to
sterilization pouch; Instructions
for Use (IFU) supplied separately. | Adhesive-backed label with
preprinted information applied
to sterilization pouch;
Instructions for Use (IFU)
supplied separately. | Identical |
| Protective
Cap and
Lubricating
Tip Assembly | Protective rigid cap with thumb
loop over one-piece molded
silicone-like lubricant reservoir
which retains catheter tip. | Protective rigid cap with thumb
loop over one-piece molded
silicone-like lubricant reservoir
which retains catheter tip. | Identical |
| Catheter
Body | Straight and Coude (curved tip)
14 Fr, medium soft catheter tube
with rounded, sealed proximal
(patient contact) tip with two (2)
offset inlet holes on opposite
sides of the catheter; catheter
length nominally 45 cm. | Straight 14 Fr medium soft
catheter tube with rounded,
sealed proximal (patient
contact) tip with two (2) offset
inlet holes on opposite sides of
the catheter; overall catheter
length nominally 40 cm. | Substantially
equivalent;
Coude tip
substantially
equivalent to
Bever
Medical
Tiemann Tip
K111405 |
| Device
Attribute | PerfIC Cath™ [Straight and
Coude Tip Models with either
Gel or Hydrophilic Coating | PerfIC Cath™ original Kit
K103043 | Equivalent |
| Protective
Outer Sheath | Outer sheath over sterile
catheter body made of low
density polyethylene; length
sufficient to seal between
reservoir tip and collection bag
entrance port effecting retention
of catheter tip at entrance to
lubricate reservoir; sheath
material nominally 0.002" thick. | Outer sheath over sterile
catheter body made of
polypropylene with 4% silicone;
length sufficient to seal between
reservoir tip and collection bag
entrance port effecting
retention of catheter tip at
entrance to lubricate reservoir;
sheath material nominally
0.004" thick. | Substantially
Equivalent |
| Urine
Collection
Bag | Collection bag pre-attached to
catheter assembly; 1000-ml
volume; flat 11 cm x 43 cm. | Collection bag pre-attached to
catheter assembly; 900-ml
volume; flat 11 cm x 41 cm. | Substantially
Equivalent |
| Sterility | Entire package sterilized via
ebeam irradiation to Sterility
Assurance Level of 10-6. | Entire package sterilized via
electron beam irradiation to
Sterility Assurance Level of 10-6. | Identical |
| Biocompati-
bility | Patient contact materials tested
according to ISO 10993-1:2009,
including: Cytotoxicity, Dermal
Sensitization, and Irritation
(vaginal). | Patient contact materials tested
according to ISO 10993-1:2009,
including: Cytotoxicity, Dermal
Sensitization, and Irritation
(vaginal). | Substantially
Equivalent |
| Lubricant | Aqueous lubricant gel or
hydrophilic coating-with-water
sachet | Aqueous lubricant gel | Substantially
Equivalent |
| Catheter
Advancement
Force | Force to advance catheter
through lubricant reservoir ≤ 1.5
newtons (0.33 pounds). | Force to advance catheter
through lubricant reservoir ≤ 1.5
newtons (0.33 pounds). | Identical |
| Bond Tensile
Strength | Sheath to lubricant reservoir &
sheath to collection bag inlet
bond strength ≥ 2.2 newtons (0.5
pounds). | Sheath to lubricant reservoir &
sheath to collection bag inlet
bond strength ≥ 2.2 newtons
(0.5 pounds). | Identical |
| Overall
Catheter
Tensile
Strength | Separation/Disassembly tensile
strength of flexible reservoir
component ≥ 15 newtons (3.37
pounds) | Separation/Disassembly tensile
strength of flexible reservoir
component ≥ 15 newtons (3.37
pounds) | Identical |
6
Conclusions:
The modified PerflC Cath™ devices are substantially equivalent to the predicate PerflC Cath™, and the curved Coude tip is substantially equivalent to the reference predicate, the Bever Medical Intermittent Catheter with a Tiemann Tip.