(99 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and safety of a capillary blood sampling lancet, with no mention of AI or ML technologies.
No.
The document states that the safety lancet is intended for capillary blood sampling, which is a diagnostic or collection procedure, not a therapeutic treatment.
No
Explanation: The device, a safety lancet, is used for capillary blood sampling, which is a collection of a sample, not a diagnostic act in itself. Diagnosis happens after the sample is analyzed.
No
The device description clearly outlines multiple physical components (needle core, button, housing, spring, etc.) and describes a physical function (capillary blood sampling). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "capillary blood sampling." This describes the collection of a biological sample, not the testing or analysis of that sample to diagnose a condition or provide information about a physiological state.
- Device Description: The device is a "safety lancet," which is a tool for obtaining a blood sample. The description focuses on the mechanical components and sterilization of the lancet itself.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of test, analysis, or measurement on the blood sample. It simply facilitates the collection of the sample.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. A lancet is a tool used in vivo (on the body) to obtain the specimen.
N/A
Intended Use / Indications for Use
The safety lancet is intended for capillary blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The safety lancet is single use medical device, which is designed to collect capillary blood sample.
The intended users include Healthcare personnel, patients and lay persons.
According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference.
For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
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
Healthcare personnel, patients and lay persons.
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 bench testing performed verifies that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics. These tests are as follow.
- Appearance: The surface shall be free of burr and no scratches. Results: Meet the requirement.
- Dimension: Product dimensions shall be consistent to the drawings. Results: Meet the requirement.
- Cleanness: No dust, no grease, no hair, no dirt. Results: Meet the requirement.
- Firmness: Needle should connect firmly with plastic handle. Results: Meet the requirement.
- Resistance to corrosion: Corrosion resistance of needle of lancet shall show no evidence of corrosion. Results: Meet the requirement.
- Acidity or Alkalinity: The pH value of an extract prepared refers to ISO 9626 Annex A shall be within one pH unit of that of the control fluid. Results: Meet the requirement.
- Limits for Extractable Metals: When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. Results: Meet the requirement.
- Puncture depth: Use calipers to measure and meet the requirements. Results: Meet the requirement.
- Launch performance: Launch performance should be good, launch button press smoothly, no jam. Results: Meet the requirement.
- Puncture force: The needle tip of the needle should have good puncture ability. Results: Meet the requirement.
- Lubricant: Visual, should not be visible droplets. Results: Meet the requirement.
- Disposable: Safety lancet should be single use, no second launch after used. Results: Meet the requirement.
- Safety Feature: The force to activate the safety feature : 4 - 15N. Test access to the sharp: the needle shall not touch the sphere. Results: Meet the requirement.
Biocompatibility Testing:
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process". The tests include the following tests:
- In Vitro Cytotoxicity (ISO 10993-5: 2009): No Cytotoxicity.
- Skin Sensitization (ISO 10993-10: 2010): No Skin sensitization.
- Intracutaneous reactivity (ISO 10993-10: 2010): No irritation.
- Acute Systemic Toxicity (ISO 10993-11: 2017): No Acute Systemic Toxicity.
- Pyrogenicity (ISO 10993-11: 2017): no thermogenic reaction.
Simulated Clinical Use:
A simulated clinical use study was performed on 500 device samples each for the Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
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
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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May 19, 2022
Tianjin Huahong Technology Co., Ltd. % Ms. Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555. Jingan District Shanghai, 200072 China
Re: K220370
Trade/Device Name: Safety Lancet (8 Models: XIII, XVII, XXII, XXIII, XXIV, XXV, XXVI) Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class II Product Code: FMK Dated: April 18, 2022 Received: April 18, 2022
Dear Ms. Situ:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220370
Device Name Safety Lancet (8 models: XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXV, XXVI)
Indications for Use (Describe) The safety lancet is intended for capillary blood sampling.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) summary-K220370
l Submitter
Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China
Establishment Registration Number: 3009498536
Primary Contact person
Ms. Ying Yuan Quality Manager Tel.: +86-15302127671 E-mail: ying.yuan@hh-technology.com
Submission Correspondent
Ms. Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Tel.: +86-13636633633 E-mail: stuart.situ@landlink-healthcare.com
Preparation date: Jan 28, 2022
II Proposed Device
| Trade Name of Device: | Safety Lancet (8 models: XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) |
|---|---|
| Common name: | Single Use Only Blood Lancet With An Integral Sharps Injury |
| Prevention Feature | |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product code: | FMK |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
510(k) Number: K192666
4
| Trade name: | VeriFine Safety Lancet |
|---|---|
| Classification: | Class I |
| Product Code: | FMK |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd. |
IV Device description
The safety lancet is single use medical device, which is designed to collect capillary blood sample.
The intended users include Healthcare personnel, patients and lay persons.
According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference.
For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
V Indication for use
The safety lancet is intended for capillary blood sampling.
VI Comparison of technological characteristics with the predicate devices
The comparison and discussion between the subject device and the predicate devices are listed in below table 1:
| Item | Proposed device | Predicate device
(K192666) | Discussion |
|--------------|-----------------|-------------------------------|------------|
| Product name | Safety Lancet | VeriFine Safety Lancet | Same |
| Product Code | FMK | FMK | Same |
Table 1 General Comparison of Safety Lancet
5
| Regulation
No. | 21 CFR § 878.4850 | 21 CFR § 878.4800 | Simila
r¹ |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--------------|
| Class | II | I | Simila
r¹ |
| Prescription/
over-the-cou
nter use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Indication for
use | The safety lancet is intended
for capillary blood sampling. | It is intended for capillary
blood sampling. | Same |
| Safety
protection
features | Yes | Yes | Same |
| Reuse
durability | Single use | Single use | Same |
| Sterilization
method and
SAL | Sterilized by Radiation
SAL=10-6 | Sterilized by Radiation
SAL=10-6 | Same |
| Self-life | 5 years | 5 years | Same |
| Materials of
parts in
contact with
human body | Needle core ( contain
needle ) : PE,PP, Calcium
powder(main ingredient:
calcium carbonate),
stainless steel (needle) ,
silicone oil (needle);
Housing, Button, Bottom,
Protective cap, Small lid,
Depth adjuster ring: ABS,PS | Needle: stainless steel
Other parts: plastics
materials | Simila
r2 |
| Biocompatibil
ity | Conforms to the
requirements of ISO 10993
series standards. | Conforms to the
requirements of ISO 10993
series standards. | Same |
| Label/Labelin
g | Complied with 21 CFR part
801 | Complied with 21 CFR part
801 | Same |
1 The classification and Regulation number are different because FDA issued the
6
final order about Reclassification of Blood Lancets on 11/22/2021.
² The raw materials of proposed devices may be different from the predicate devices. However, all the materials are known biocompatible materials that have been used in lancets or other similar medical devices.
VII Non-Clinical Testing
The bench testing performed verifies that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics. These tests are as follow.
| Items | Acceptance criteria | Results |
|---|---|---|
| Appearance | The surface shall be free of burr and no scratches. | Meet the requirement |
| Dimension | Product dimensions shall be consistent to the drawings | Meet the requirement |
| Cleanness | No dust, no grease, no hair, no dirt | Meet the requirement |
| Firmness | Needle should connect firmly with plastic handle: | Meet the requirement |
| Resistance to corrosion | Corrosion resistance of needle of lancet shall show no evidence of corrosion. | Meet the requirement |
| Acidity or Alkalinity | The pH value of an extract prepared refers to ISO 9626 Annex A shall be within one pH unit of that of the control fluid. | Meet the requirement |
| Limits for Extractable Metals | When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Meet the requirement |
| Puncture depth | Use calipers to measure and meet the requirements. | Meet the requirement |
| Launch performance | Launch performance should be good, launch button press smoothly, no jam | Meet the requirement |
| Puncture force | The needle tip of the needle should have good puncture ability. | Meet the requirement |
| Lubricant | Visual, should not be visible droplets. | Meet the requirement |
| Disposable | Safety lancet should be single use, no second launch after used. | Meet the requirement |
| Safety Feature | The force to activate the safety feature : 4 - 15N | Meet the requirement |
| Test access to the sharp: the needle shall not touch the sphere. |
7
Biocompatibility Testing:
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" . The tests include the following tests:
| Item | Test method | Test results |
|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | No Cytotoxicity |
| Skin Sensitization | ISO 10993-10: 2010 | No Skin sensitization |
| Intracutaneous reactivity | ISO 10993-10: 2010 | No irritation |
| Acute Systemic Toxicity | ISO 10993-11: 2017 | No Acute Systemic |
| Toxicity | ||
| Pyrogenicity | ISO 10993-11: 2017 | no thermogenic reaction |
Simulated Clinical Use
A simulated clinical use study was performed on 500 device samples each for the Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
VIII Clinical Testing
No clinical study is included in this submission.
IX Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated K220370
8
device. Accordingly, the proposed device is substantially equivalent to the predicate device.