(304 days)
KLS Sonic Weld Sonic Pin
No
The summary describes a mechanical and thermal system for delivering a resorbable polymer, with no mention of AI or ML capabilities for analysis, decision-making, or control.
No.
The device is described as an injectable polymer system used for bone fixation and reconstruction, which is a structural or mechanical function, rather than a therapeutic one that treats a disease or condition.
No
This device is intended for non-load bearing fracture repair and reconstructive procedures, acting as a fastener for plates, sheets, and for maintaining the relative position of bony fragments or grafts. It is a surgical implant device, not a diagnostic one.
No
The device description clearly outlines hardware components including a battery-powered delivery device, a polymer rod, a power drive unit, a plastic shell and cap, and a battery pack. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation of bone in the craniofacial skeleton. This is an in-vivo application, meaning it is used within the living body.
- Device Description: The description details a system for delivering a polymer into a predrilled hole in bone for fixation. This is a mechanical and material-based approach to surgical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed to be implanted within the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, and sheets.
In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).
Product codes
HBW
Device Description
DePuy Synthes RAPIDSORB IPS Injectable Polymer System consists of a sterile resorbable polymer, 85:15 Poly (L-lactide co-glycolide) and a battery powered delivery device. The polymer can be extruded from the delivery device into a predrilled pilot hole at the surgical site.
The polymer is presented as a rod in a sterile package (cartridge) that fits into the delivery device. The device then briefly heats the polymer at the implant site beyond the glass transition temperature of the polymer, allowing the polymer to be extruded in a controlled manner in a preselected length from the device through a plate, mesh, or sheet and into a predrilled hole at the site of the defect. The extruded polymer fills the predrilled hole. Retention is attained through friction and interdigitation with the surrounding bone.
The delivery device consists of three principal components: 1) a Power Drive Unit, which is nonsterile and reusable, and which fits into and is enclosed by 2) a disposable, sterile, single-use, rigid plastic shell and cap, and 3) a sterile, single-use, battery pack that attaches to the shell and serves as the power source. The delivery device is comfortably shaped and balanced to fit the left or right hand of the surgeon.
Enclosing the Power Drive Unit thus assures sterile delivery of the polymer at the implant site. The brevity of the increase in the temperature of the polymer combined with the controlled, minimized volume of polymer implanted prevents tissue injury or necrosis at the implant site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton (excluding the upper and lower jaw)
Indicated Patient Age Range
pediatric and adult populations.
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)
Nonclinical Tests:
- ISO Guinea Pig Maximization Sensitization Test: Tested RAPIDSORB IPS Delivery Device Shell, Battery Shell using Guinea pigs. Result: Pass.
- IEC 60601-1 (ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012): Accredited laboratory tests of compliance with the medical device electrical standards of IEC 60601 including software of the Power Drive unit, shell, cap and battery. Result: Pass.
- Controlled Extraction Study: Tested 85: 15 poly (L-lactide- co-glycolide). The polymer in the IPS submission was found to be identical to the cleared polymers.
- ISO Intra-cutaneous Reactivity Test: Tested RAPIDSORB IPS Delivery Device Shell, Battery Shell using three male NZW rabbits. Result: Pass. There were no significant dermal reactions observed.
- ISO MEM Elution Assay with L-929 Mouse Fibroblast Cells: Tested RAPIDSORB IPS Delivery Device Shell, Battery Shell. Result: Pass. The test article did not induce cytotoxicity.
- ISO Acute systemic Injection Test: Tested RAPIDSORB IPS Delivery Device Shell, Battery Shell using mice. Result: Pass.
In Vitro and Animal Tests Demonstrating Substantial Equivalence:
- Axial Pullout Test (in vitro bench test): Compared pullout strength of 2 different IPS fasteners lengths to a 1.5 x 3mm (length) Direct Drive Lactosorb Screw. Result: At each time point, the pullout strength, measured in Newtons, was significantly greater for the Rapidsorb IPS Fastener compared to the predicate Lactosorb.
- Shear Testing (in vitro bench test): Compared initial and degraded strength of the IPS fastener to that of the predicate Lactosorb Fastener at comparable time points. Result: Based on statistical comparison of data, the mean peak load of the Rapidsorb IPS fastener was superior to the mean peak load for the Lactosorb fastener.
- Immature ovine model animal test: Compared thermal effects of the IPS fastener to that of the KLS Sonic Weld Sonic Pin. Result: Evaluation of bone and soft tissues (dura matter and brain) associated with cranial implant sites treated with Rapidsorb IPS fasteners and the predicate Sonic Weld Sonic Pin fasteners demonstrated comparable biocompatibility, irritancy scores, and healing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes (USA) Rapid Resorbable Tack System (K050204), Synthes (USA) Rapid Resorbable Fixation System (K062789), KLS-Martin, L.P., SonicWeld RX (Resorb-X) (K080862), Biomet Inc., Lactosorb Trauma Plating System (K992355)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2015
Depuy Synthes Biomaterials Jeffrey L. Dow, JD Senior Principal Regulatory Affairs Strategy Advisor 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K141385
Trade/Device Name: Depuy Synthes RAPIDSORB Injectable Polymer System (IPS) Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: HBW Dated: February 23, 2015 Received: February 26, 2015
Dear Mr. Dow,
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Carlos L. Pena -SFD/△
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141385
Device Name RAPIDSORB Injectable Polymer System (IPS)
Indications for Use (Describe)
The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, and sheets.
In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | K141385 | |
|---|---|---|
| Submitter: | DePuy Synthes Biomaterials | |
| 1230 Wilson Drive | ||
| West Chester, PA 19380 | ||
| Date of creation: | February 23, 2015 | |
| Company Contact: | Jeffrey L. Dow, JD | |
| Senior Principal R/A Strategy Advisor | ||
| DePuy Synthes Biomaterials | ||
| 484 467 4174 | ||
| Fax: 484 356 9636 | ||
| dow.jeff@synthes.com | ||
| Name of Device: | DePuy Synthes RAPIDSORB® Injectable Polymer System (IPS) | |
| Device Classification: | Class II, 21 CFR § 882.5360 | |
| Product Code: | HBW | |
| Common Name: | Cranioplasty Plate Fastener | |
| Predicate Devices: | ||
| (Please see Table 1, below) | Synthes (USA) Rapid Resorbable Tack System (K050204) | |
| Synthes (USA) Rapid Resorbable Fixation System (K062789) | ||
| (Principal Predicate) KLS-Martin, L.P., SonicWeld RX (Resorb- | ||
| X) (K080862) | ||
| Biomet Inc., Lactosorb Trauma Plating System (K992355) | ||
| Indications for Use: | The RAPIDSORB Injectable Polymer System (IPS) is indicated | |
| for use in non-load bearing fracture repair and reconstructive | ||
| procedures of the craniofacial skeleton (excluding the upper and | ||
| lower jaw) in pediatric and adult populations. RAPIDSORB IPS | ||
| fasteners are designed to be used for the fixation of RAPIDSORB | ||
| plates, meshes, and sheets. | ||
| In addition, RAPIDSORB IPS implants and instruments may be | ||
| used with RAPIDSORB meshes and sheets in non-load bearing | ||
| applications for maintaining the relative position of, and/or | ||
| containing, bony fragments, bone grafts, (autograft or allograft), or | ||
| bone graft substitutes in craniofacial reconstruction (excluding the | ||
| upper and lower jaw)." |
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DePuy Synthes Synthes (USA) Rapid Synthes (USA) Rapid (Principal Predicate) KLS-Martin, Biomet Inc., Lactosorb Trauma Plating System RAPIDSORB® Iniectable Resorbable Tack System Resorbable Fixation System LP., SonicWeldRX (Resorb X) (K992355) Polymer System (IPS) (K050204) (K062789) (K080862) (K141385) Indications. DePuy Synthes Indication. Synthes Rapid Indication. The Synthes (USA) Indication.The KLS Martin Indication: trauma procedures of the midface or RAPIDSORB Injectable Resorbable Tack System is Rapid Resorbable Fixation SonicWeld RX (Resorb X) is craniofacial skeleton Polymer System (IPS) is intended for use in fracture System is intended for use in intended for use in fracture repair Specific Indications: repair and reconstructions of the intended for use in non-load fracture repair in reconstructive and reconstructive procedures of 1. Comminuted fractures of the naso-ethmoidal bearing fracture repair and craniofacial skeleton. In procedures of the craniofacial the craniofacial skeleton in infraorbital areas reconstructive procedures of the addition, Rapid Resorbable skeleton in pediatric and adult pediatric and adult populations. In 2. Comminuted fractures of the frontal sinus wall craniofacial skeleton (excluding Tacks may be used in non-load populations. In addition. addition, resorbable meshes, plates. 3. Pediatric midface or craniofacial trauma the upper and lower jaw) in bearing applications for resorbable meshes, sheets, screws and pins may be used in 4. LeFort (I,II,III) fractures pediatric and adult populations. maintaining the relative position screws and tacks may be used in non-load bearing applications for 5. Orbital floor fractures RAPIDSORB IPS fasteners are and/or containing bony non-load bearing applications maintaining the relative position of. 6. Fractures of the maxilla, zygoma, zygomatic arch, designed to be used for the fragments, bone grafts (autograft for maintaining the relative and/or containing, bony fragments, orbital rim, nasal,ethmoid, and lacrimal bones position and/or containing, bony bone grafts (autograft or allograft), 7. Trauma of the craniofacial skeleton including: frontal, fixation of DePuy Synthes or allograft) or bone graft RAPIDSORB plates, meshes, substitutes in reconstruction of fragments, bone grafts, or bone graft substitutes in parietal, temporal, sphenoid, and occipital bones and sheets. the craniofacial or mandibular (autograft or allograft) or bone reconstruction of the craniofacial or General Indication: reconstructive procedures of the mandibular areas. midface or craniofacial skeleton areas. graft substitutes in In addition, RAPIDSORB IPS reconstruction of the Specific Indications: implants and instruments may be craniofacial or mandibular areas. 1. Infant craniofacial surgery (i.e.craniosynostosis, used with RAPIDSORB meshes congenital malformation, trauma, etc.) and sheets in non-load bearing 2. LeFort (I,II,III) osteotomies applications for maintaining the 3. Tumor reconstruction in midsface or craniofacial relative position of, and/or procedures 4. Bone graft procedures in the midface or craniofacial containing, bony fragments. bone grafts, (autograft or skeleton allograft), or bone graft 5. Pediatric reconstructive procedures 6. Reconstructive procedures of the craniofacial skeleton substitutes in craniofacial reconstruction (excluding the including: frontal, parietal, temporal, sphenoid, and upper and lower jaw). occipital bones 7. Craniotomy flap fixation Procode JEY 872.4760 Procode JEY 872.4760 Procode: HBW, 882.5360 Procode JEY 872.4760 Procode HRS, HWC 888.3030 Material: 85:15 Poly (L-lactide Material: 85:15 Poly (L-lactide Material: 85:15 Poly (L-lactide Material: Poly (D, L)-Lactide-Acid Material: 82 poly L-lactide acid and 18% poly glycolic co-glycolyde) co-glycolyde) co-glycolyde) acid Biocompatibility: Established Biocompatibility: Established Biocompatibility: Established Biocompatibility: Established Biocompatibility: Established Resorption time: Approximately Resorption time: Approximately Resorption time: Approximately Resorption time: unknown Resorbtion time: Approximately 12 months 12 months 12 months 12 months Sterile components: Single use Sterile components: Single use Sterile components: Single use Sterile components: Single use Sterile components: Single use only; Gamma or EtO only; Gamma or EtO sterilized only; Gamma or EtO sterilized only; Gamma or EtO sterilized only; Gamma or EtO sterilized sterilized
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TABLE 1: COMPARISON OF INDICATIONS AND TECHNOLOGIES BETWEEN IPS AND PREDICATES
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Device Description: DePuy Synthes RAPIDSORB IPS Injectable Polymer System consists of a sterile resorbable polymer, 85:15 Poly (L-lactide co-glycolide) and a battery powered delivery device. The polymer can be extruded from the delivery device into a predrilled pilot hole at the surgical site.
The polymer is presented as a rod in a sterile package (cartridge) that fits into the delivery device. The device then briefly heats the polymer at the implant site beyond the glass transition temperature of the polymer, allowing the polymer to be extruded in a controlled manner in a preselected length from the device through a plate, mesh, or sheet and into a predrilled hole at the site of the defect. The extruded polymer fills the predrilled hole. Retention is attained through friction and interdigitation with the surrounding bone.
The delivery device consists of three principal components: 1) a Power Drive Unit, which is nonsterile and reusable, and which fits into and is enclosed by 2) a disposable, sterile, single-use, rigid plastic shell and cap, and 3) a sterile, single-use, battery pack that attaches to the shell and serves as the power source. The delivery device is comfortably shaped and balanced to fit the left or right hand of the surgeon.
Enclosing the Power Drive Unit thus assures sterile delivery of the polymer at the implant site. The brevity of the increase in the temperature of the polymer combined with the controlled, minimized volume of polymer implanted prevents tissue injury or necrosis at the implant site.
Nonclinical Tests (Please see Tables 2 And 3 Below)
Biocompatibility testing of the IPS polymer implant and delivery device was performed in accordance with the applicable FDA guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" July 28, 2014, and applicable International Standards Organization requirements of ISO 10993 for implants of greater than 30 days duration, as well as those standards for brief patient contact. The results of all those tests showed that the IPS polymer implant and delivery device are biocompatible. '
1 The term "substantial equivalence" as used in this 510(k) notification of substantial equivalence found in the Federal Food, Drug and Cosmetic Act 21 USC $301 et seq., as amended, and as applied under 21 CFR Part 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalence under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in substantial equivalence herein may be construed as an admission against interest under the US patent laws or their application by the courts.
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TABLE 2: NONCLINICAL TESTS SUMMARY,
| Title | Test Article | Methods | Conclusion |
|---|---|---|---|
| ISO Guinea Pig Maximization | |||
| Sensitization Test | RAPIDSORB IPS Delivery | ||
| Device Shell, Battery Shell | Guinea pigs were injected with test article extract and FCA, | ||
| and the same number guinea pigs were injected with control | |||
| blank and FCA. Test animals were topically patched with | |||
| test extract and control animals were patched with control | |||
| blank. Patches were removed after 48 hours. After 2 weeks, | |||
| the animals were patched with test extract and control blank. | |||
| This test was conducted in accordance to ISO 10993-10:2010 | |||
| part 10: Test for irritation and skin sensitization. | Pass. | ||
| IEC 60601-1 | |||
| (ANSI/AAMI ES60601- | |||
| 1:2005/(R)2012 and C1:2009/(R)2012 | |||
| and A2:2010/(R)2012) | Accredited laboratory tests of | ||
| compliance with the medical | |||
| device electrical standards of | |||
| IEC 60601including software of | |||
| the Power Drive unit, shell, cap | |||
| and battery | Such tests as are required for certification under | ||
| ANSI/AAMI ES60601-1:2005/(R)2012 and | |||
| C1:2009/(R)2012 and A2:2010/(R)2012 | Pass. | ||
| Controlled Extraction Study | 85: 15 poly (L-lactide- co- | ||
| glycolide) | The polymer cleared in K030069, K050204, and K062789 | ||
| was compared to the polymer described in the IPS | |||
| submission to establish its identity to the cleared polymer. | |||
| This test followed test guidelines described in ISO 10993- | |||
| 18:2005. | The polymer in the IPS submission | ||
| was found to be identical to the cleared | |||
| polymers. | |||
| ISO Intra-cutaneous Reactivity Test | RAPIDSORB IPS Delivery | ||
| Device Shell, Battery Shell | Test article was extracted at a ratio of 4 g to 20 mL in normal | ||
| saline and sesame oil for 72 hours at 50°C. Test articles and | |||
| vehicle controls were injected into three male NZW rabbits. | |||
| Rabbits were observed at 24, 48, and 72 hours. This test was | |||
| performed in accordance with ISO 10993-10:2010 | Pass. | ||
| There were no significant dermal | |||
| reactions observed. | |||
| ISO MEM Elution Assay with L-929 | |||
| Mouse Fibroblast Cells | RAPIDSORB IPS Delivery | ||
| Device Shell, Battery Shell | The test article was extracted in E-MEM + 5% FBS for 24 | ||
| hours at 37°C. The L-929 cells were incubated with the extract | |||
| for 72 hours. The cultures were evaluated for cytotoxic effects | |||
| by microscopic examination at 24, 48, and 72 hours.. This test | |||
| was performed in accordance with ISO 10993-5:2009 | Pass. | ||
| The test article did not induce | |||
| cytotoxicity. | |||
| ISO Acute systemic Injection Test | RAPIDSORB IPS Delivery | ||
| Device Shell, Battery Shell | Mice were treated by intravenous or intraperitoneal injection | ||
| to screen for potential toxic effects as a result of a single-dose | |||
| systemic injection as recommended in ISO 10993-11:2006. | Pass. |
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| TABLE 3: IN VITRO AND ANIMAL TESTS DEMONSTRATING SUBSTANTIAL |
|---|
| EQUIVALENCE. |
| Test | Test Method Summary | Results |
|---|---|---|
| Axial Pullout Test | The object of this in vitro | |
| bench test was to determine | ||
| the pullout strength of 2 | ||
| different IPS fasteners lengths | ||
| compared to the predicate, a | ||
| 1.5 x 3mm (length) Direct | ||
| Drive Lactosorb Screw. | ||
| Measurements were made at | ||
| time points as the test | ||
| materials degraded. | At each time point, the pull | |
| out strength, measured in | ||
| Newtons, was significantly | ||
| greater for the Rapidsorb IPS | ||
| Fastener compared to the | ||
| predicate Lactosorb. | ||
| Shear Testing | The object of this in vitro | |
| bench test was to compare the | ||
| initial and degraded strength | ||
| of the IPS fastener to that of | ||
| the predicate Lactosorb | ||
| Fastener at comparable time | ||
| points. | Based on statistical | |
| comparison of data, the mean | ||
| peak load of the Rapidsorb | ||
| IPS fastener was superior to | ||
| the mean peak load for the | ||
| Lactosorb fastener. | ||
| Immature ovine model animal | ||
| test | An animal test in an immature | |
| ovine model was undertaken | ||
| to show the thermal effects of | ||
| the IPS fastener compared to | ||
| that of the KLS Sonic Weld | ||
| Sonic Pin. | Evaluation of bone and soft | |
| tissues (dura matter and brain) | ||
| associated with cranial | ||
| implant sites treated with | ||
| Rapidsorb IPS fasteners and | ||
| the predicate Sonic Weld | ||
| Sonic Pin fasteners | ||
| demonstrated comparable | ||
| biocompatibility, irritancy | ||
| scores, and healing |
Conclusion.
Performance testing of the RAPIDSORB IPS has demonstrated that the subject device is substantially equivalent to the predicate devices.