(87 days)
Not Found
No
The device description and performance testing focus on the physical properties and function of a simple abrasive pad, with no mention of computational or algorithmic processes.
No
The device is described as an electrosurgical accessory used to clean cauterization blades and does not directly interact with or treat a patient.
No
Explanation: The device is described as an electrosurgical accessory used to remove eschar buildup from cauterization blades. Its function is to facilitate the cleaning of surgical tools, not to diagnose medical conditions or provide information about a patient's health status.
No
The device description clearly outlines a physical product composed of foam, abrasive material, and adhesive, intended for manual use during surgery. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a sterile single-use tip cleaner used to remove eschar buildup from electrosurgical cauterization blades during surgical procedures. It is an accessory to a surgical tool and does not interact with patient samples for diagnostic purposes.
- Intended Use: The intended use clearly states it's for removing eschar from surgical blades, not for analyzing biological samples.
- Device Description: The description focuses on the physical components and how it functions to clean the blade, not on any biological or chemical analysis.
- Performance Studies: The performance studies evaluate physical characteristics like appearance, adhesion, and residual testing, which are relevant to a surgical accessory, not an IVD.
The device is a surgical accessory used to maintain the functionality of another surgical device (the electrosurgical cauterization blade). It does not perform any diagnostic testing on patient samples.
N/A
Intended Use / Indications for Use
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
Product codes
GEI
Device Description
The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)×5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical Performance Testing was conducted.
Key results:
- Appearance: The surface of the product should be clean, free from damage, cracking, or other undesirable phenomena. PASS. The product sandpaper surface, sponge base layer, pressure-sensitive adhesive, X-ray ray, and release paper should be tightly bonded together, and there should be no curling or falling off. PASS.
- Product performance: The double-sided adhesive has good adhesion, smoothness and no warping. PASS. There is no sand falling off on the polishing abrasive (sandpaper) surface. PASS. The peel strength of the double-sided adhesive should be ≥2N/CM. PASS.
- Residual Testing: FTO Residual ≤4mg/pcs ECH≤9mg/pcs. PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo features the Department of Health & Human Services logo on the left. To the right of that is the FDA logo in blue, with the words "U.S. Food & Drug Administration" written in blue text.
July 11, 2024
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Haobin Li General Manager TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone HuiZhou, GuangDong 516003 China
Re: K241022
Trade/Device Name: Sterile single use tip cleaner (WK800-S10 , WK800-S20) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 20, 2024 Received: May 20, 2024
Dear Haobin Li:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Long H. Chen
Long H. Chen -S -s
Date: 2024.07.11 15:06:45 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Sterile single use tip cleaner (WK800-S10 , WK800-S20)
Indications for Use (Describe)
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
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)
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4
K241022
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. 510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with the requirements of 21 CFR 8807.92.
Type of submission :Traditional The assigned 510(K) number is:K241022 The date the summary was prepared: April 15, 2024
1. Submitter information:
Manufacturer Name: WickiMed(Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Address: TangJiao Street, LiLin Town, ZhongKai XingWang -Hi-Tech Zone, HuiZhou,GuangDong, China.
Establishment Registration Number:3010601992
Contact person:Haobin Li
Position: General Manager
Tel : 0086-0752-3860807
Fax : 0086-0752-3863017
E-mail: mac lai@wickimed.com
2. Device Information:
Trade/Common Name: Sterile single use tip cleaner Models: WK800-S10 ,WK800-S20 Regulatory Class: Class II Regulatory Number: 21 CFR 878.4400 Review Panel: General & Plastic Surgery Product Code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
3. Predicative Device
Manufacturer: Key Surgical Incorporated Trade/Device Name: Key Surgical® Cautery Tip Cleaner Product Code: GEI 510(k) Number: K151222
4. Indication for Use
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical
5
K241022
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. cauterization blades during surgical procedures.
5. Device Description
The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)×
5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
6. Comparison of Intended Use and Technological Characteristics
The Sterile single use tip cleaner predicate device is the Key Surgical, Inc., K151222, cleared on May 22, 2015. The following illustrates the similarities in the product design.
| Characteristics | Predicate Device | Proposed Device |
|---|---|---|
| Key Surgical® | ||
| Cautery Tip Cleaner | ||
| K151222 | Sterile single use tip cleaner | |
| Indications for Use | The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures. | The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures. |
| Conditions of Use | Single Use, disposable | Single Use, disposable |
| Materials | Aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. | Aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. |
| Adhesive back | Yes, for universal placement and aid in keeping the device in place. | Yes, for universal placement and aid in keeping the device in place. |
| Sterility | Provided Sterile | Provided Sterile |
| Principle of Operation | The cautery tip cleaner is used | The cautery tip cleaner is used |
Table 1 : Comparison to Predicate device
6
K241022
| | to aid in the removal of eschar
on electrosurgical blades
during surgical procedures. | to aid in the removal of eschar
on electrosurgical blades
during surgical procedures. |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interface with Electrosurgical
Cauterization Blade | The Cautery Tip Cleaner does
not impact the function of the
electrosurgical cauterization
blades. It is not required for
use with the blades, but an
accessory that aids in the
removal of eschar buildup. | The sterile single use tip
cleaner does not impact the
function of the electrosurgical
cauterization blades. It is not
required for use with the
blades, but an accessory that
aids in the removal of eschar
buildup. |
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
7. Summary of Non-clinical Performance Testing
| Item | Requirement | Result |
|---|---|---|
| 1. Appearance | 1.1The surface of the product should be clean, free from damage, cracking, or other undesirable phenomena. | PASS |
| 1.2 The product sandpaper surface, sponge base layer, pressure-sensitive adhesive, X-ray ray, and release paper should be tightly bonded together, and there should be no curling or falling off. | PASS | |
| 2.Product performance | 2.1 The double-sided adhesive has good adhesion, smoothness and no warping. | PASS |
| 2.2 There is no sand falling off on the polishing abrasive (sandpaper) surface. | PASS | |
| 2.3 The peel strength of the double-sided adhesive should be≥2N/CM. | PASS | |
| 3. Residual Testing | 3. FTO Residual ≤4mg/pcs ECH≤9mg/pcs | PASS |
| Table 2 : Non-clinical Performance Testing | |||
|---|---|---|---|
| -- | -- | -------------------------------------------- | -- |
8. Conclusion
The sterile single use tip cleaner is as safe and effective as the predicate device.